Category: Device Alerts

ANZCDACC Hazard Alert and Product Defect Correction May 2023

Device:
Cobalt™ XT/Cobalt™/Crome™ ICDs and CRT-Ds
A subset of: Claria MRI™/Amplia MRI™/Compia MRI™/Viva™/Brava™ CRT-Ds
A subset of: Visia AF™/Visia AF MRI™/Evera™/Evera MRI™/Primo MRI™/Mirro MRI™ ICDs

TGA Reference:
RC-2023-RN-00433-1

Australian Register of Therapeutic Goods (ARTG):
281611, 230019, 281610, 230021, 339481, 339487, 339482, 339489, 339483, 339490, Cancelled: 203212, Cancelled: 219221, 281607, 280186, 281608, 280183, 281606, 280184, 280182, 341548, 341556, 341553, 341549, 341551, 341557, 341554, 341550, 341552, 341555, 341547, 282960, 280354, 282961, 280355, 281609, 230020, 339484, 339491, 339485, 339488, 339486, 339492

Wand Notification Reference:
|31099
Web Assisted Notification of Devices (WANDS):
160907-WAND-6MO71M, 140408-WAND-6HEYLA, 160907-WAND-6MO6Y6, 140408-WAND-6HEYM7, 200109-WAND-6TXFRQ, 200109-WAND-6TXFST, 200109-WAND-6TXFSH, 200109-WAND-6TXFT3, 200109-WAND-6TXFVH, 200109-WAND-6TXG6G, Cancelled: 120823-WAND-6DVT1J, Cancelled: 130925-WAND-6G963U, 160901-WAND-6MMWH3, 160225-WAND-6LIENL, 160901-WAND-6MMWKA, 160225-WAND-6LIEMU, 160901-WAND-6MMWBT, 160225-WAND-6LIEL8, 160225-WAND-6LIEJE, 200109-WAND-6TXFO3, 200109-WAND-6TXFOZ, 200109-WAND-6TXFN0, 200109-WAND-6TXFJ5, 200109-WAND-6TXFOK, 200109-WAND-6TXFP9, 200109-WAND-6TXFNA, 200109-WAND-6TXFKX, 200109-WAND-6TXFQB, 200109-WAND-6TXFQ1, 200109-WAND-6TXFPN, 160908-WAND-6MOCJD, 151022-WAND-6KRD11, 160908-WAND-6MOCLI, 151022-WAND-6KRD1N, 160907-WAND-6MO6X8, 140408-WAND-6HEYN9, 200109-WAND-6TXFTE, 200109-WAND-6TXFTO, 200109-WAND-6TXFTX, 200109-WAND-6TXFU9, 200109-WAND-6TXG78, 200109-WAND-6TXG7J

Advisory grade TGA: Class I

(Class I recall action occurs when the product deficiency is potentially life-threatening or could cause a serious risk of health).

Description:
There is a rare potential for reduced or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

There is an increased potential for a reduced or no-energy HV therapy in the AX>B configuration when all the following conditions are met:

• The device has a glassed feedthrough (manufactured after July 2017).
• There is significant separation of the layers of insulation materials in the feedthrough components of the device header.
• An unintended current pathway forms within the void created by the insulation separation, capable of conducting high levels of current during HV therapy.

When an unintended current pathway is detected during HV therapy, the Short Circuit Protection (SCP) feature may trigger. SCP is a safety feature that can only occur during high voltage (HV) therapy. SCP is designed to truncate energy delivery to protect the device when an unintended current pathway is detected during a shock. This behaviour can be intermittent; both full-energy and reduced-energy HV therapies within the same episode have been observed. SCP events may also be lead related; for both lead-related and device-related unintended current pathways, the defibrillation waveform is truncated early in the energy delivery sequence, resulting in reduced or no energy being delivered (~0-12J).

There have been no deaths due to this issue in the glassed feedthrough device population, although there have been instances where external defibrillation was required to convert an arrhythmia, due to failure of the device to deliver adequate therapy.

In some cases, a persistent 50% drop in all pacing lead impedances may be displayed; however, lead function, is not affected.

Should this issue occur, pacing, sensing, episode detection, anti-tachycardia pacing (ATP) therapies, battery longevity, and telemetry remain functional.

Medtronic is updating Instructions for Use, HV therapy nominals and the programmer interfaces for these device models to be consistent with information in this report. Medtronic will release additional information once the necessary regulatory approvals have been received, as applicable in the local region.

The root cause for device related first-phase SCP events, the sequence of events and the physics of failure are still being investigated by Medtronic.

Number of devices affected in Australia and New Zealand:

Not supplied

Presentation:
As a result of shocks below the defibrillation threshold (DFT) and subsequent delay/absence of receiving successful shocks to terminate ventricular arrhythmia, patients affected by this issue may present with symptoms of hemodynamic compromise, multiple shocks and potentially sudden cardiac death.

The potential harm to the patient could also include complications associated with device replacement and/or unnecessary lead replacement if the reduced- or no-energy HV therapy is erroneously attributed to a lead failure.

Upon interrogation, the device will report in the “Episode Text” the delivered energy as less than the programmed energy, as shown in the example image below.

Rate of occurrence:
Through 10 April 2023, Medtronic has identified 27 devices from approximately 816,000 devices (representing 0.003%) distributed worldwide that have experienced a reduced or no-energy HV therapy due to the issue described above. Of these, 26 were in devices with an AX>B delivered pathway.

Based on an analysis of patients with a glassed feedthrough device and with a history of HV therapy, the observed rate for this issue is 0.03%, highlighting the observed failure rate would be much higher if all devices were required to deliver therapy.

With current field programming, devices with a glassed feedthrough may experience increased risk for reduced or no-energy output during HV therapy, projected at 5 years to be 0.02% overall and 0.48% for patients with a history of HV therapy.

Medtronic conducted a broader analysis to determine the incidence of device related reduced or no-energy HV therapy events outside of the above population, with implants dating back to 2012. Using these historical observed events, projected rates for this population of devices is 0.002% at five (5) years and 0.006% at nine (9) years. This analysis identified two deaths due to this issue in the brazed feedthrough device population suggesting a device-related reduced or no-energy HV therapy occurred.

When devices in the glassed feedthrough population are programmed exclusively in the B>AX configuration, the overall potential for a reduced or no-energy HV therapy is 0.002% at five (5) years and 0.005% at nine (9) years, comparable to historical device performance.

Recommendation:

Individual devices susceptible to this issue can be identified via search/look-up on the Medtronic Product Performance Report Website (http://productperformance.medtronic.com).

• Prophylactic device replacement is NOT recommended.
  • The risk of mortality for patients after reprogramming is 0.001% at 9 years and is less than the risk of patient mortality due to complications associated with device replacement (0.032% – 0.043% ^1,2,3).
• Program all HV therapy pathways B>AX in all therapy zones to minimise the risk for this issue.
  • Note: Using “Get Medtronic Nominals” will require manual reprogramming of Rx5 and Rx6 to B>AX for all ventricular therapies.
• Prioritise reprogramming patients who are at the highest risk:
  • Namely those who have a history of HV therapy and/or secondary prevention indication AND Rx1 programmed AX>B.
    • Rx1 provides the greatest statistical likelihood to resolve an arrhythmia, and therefore it is important to minimise risk of a reduced or no-energy HV therapy in the first sequence.
    • Ask your local Medtronic Representative to arrange a search for these high-risk patients on Carelink.
  • For remaining patients with AX>B programming in any HV therapy sequence, schedule (with appropriate discretion) the next follow-up for in-clinic reprogramming to minimise potential for reduced or no-energy HV therapies to occur.
  • Per standard practice, check tachyarrhythmia episodes to determine effectiveness of therapies that have been delivered.
    • Instruct patients to contact the clinic if they receive HV therapy or hear an audible tone coming from their device.
    • Verify delivered energy is consistent with programmed energy in the Episode
  • Contact your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue:
    • Reduced- or no-energy HV therapy is displayed in Episode Text (regardless of programmed pathway)
    • A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy.

1. Tarakji KG, et al. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. The New England Journal of Medicine. 2019; 380(20):1895-1905.
2. Medtronic Data on File. MDT2260884-CRHF CIED Infection Report; Agile: MDT2260884, Version 2.0, 11/02/2015.
3. Birnie D, et al. Complications associated with defibrillation threshold testing: The Canadian experience. Heart Rhythm. 2008; 5(3):387-90.

The ANZCDACC encourage you to report any adverse event or near (potential) adverse event associated with the use of a medical device including any abnormal CIED or lead function. We encourage reporting to ANZCDACC directly via the Committee chair Dr Paul Gould [email protected] and to the following regulators.

 In Australia, report to the TGA;

Online

https://www.tga.gov.au/reporting-problems

In New Zealand, report to Medsafe;

Post	Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6145.
Email	[email protected]
Fax	04 819 6806

 

ANZCDACC Field Safety Notice 15^th of March 2021
Device: A subset of Abbott / St Jude Medical Assurity ™ and Endurity ™ Pacemakers
Models: PM1160, PM1172, PM1240, PM1272, PM2160, PM2172, PM2240, PM2260*, PM2272

TGA Reference: RC-2021-RN-00728-1
Australian Register of Therapeutic Goods (ARTG): 216288, 267515, 216284, 267512, 216289, 267514, 216285, 216287*, 267513
*TGA listing cancelled in June 2019

Advisory grade TGA: TBA

ANZDACC Advisory Grade: Routine

Description:

 Abbott’s post market surveillance process has identified a subset of Assurity ™ and Endurity ™ pacemakers that have an increased chance of moisture ingress into the pulse generator header, caused by intermittent, incomplete mixing of epoxy during manufacture on specific equipment between 2015 and 2018. These units were from a manufacturing process which is no longer in use. No affected devices remain available for implant.
There have been no reports of serious harm to patients as a result of this issue.

 Number of devices affected in Australia and New Zealand:
There have been 70 devices in Australia and 28 in New Zealand which are included in the identified subset.

Presentation:
The reported clinical impact has included loss of telemetry / communication, reduced battery longevity, loss of pacing, and/or shortened duration between Elective Replacement Indicator (ERI) and End of Service (EOS). Forty-eight (48) devices were returned with an associated report suggesting loss of pacing. Additionally, twenty-one (21) returned devices reached ERI earlier than expected with an average of 17 days from ERI to EOS.

Rate of occurrence:

Abbott has identified a subset of approximately 95,000 devices within the referenced timeframe that are potentially susceptible to this issue.

 Due to the intermittent nature of the incomplete epoxy mixing, the potential for affected devices is inconsistently dispersed between 2015 and 2018. To date, 135 devices have been observed with this issue. A low observed rate (0.049%) of malfunctions has been detected among the identified subset of devices.

Recommendation:

Prophylactic generator replacement is not recommended by Abbott or ANZCDACC due to the very low rate of occurrence and the low potential for harm when prompt replacement is performed following an unexpected ERI/EOS alert.

1. If possible, monitor patients via remote monitoring to benefit from alert monitoring between routine device checks. (ERI and EOS alerts are currently monitored daily).
   1. If remote monitoring is not possible, 3 monthly in-clinic checks are recommended for those who are pacemaker dependent.
   2. If remotely monitored and pacemaker dependent;
      1. Reduce the disconnected transmitter thresholds on Merlin.net, in the transmitter section of the patient profile, to the minimum option of 7 days.
      2. Promptly respond to disconnected transmitter (monitor) and patient’s DirectAlert™ Check status alerts, summarised each week in the “Communication Centre.”
   3. During follow-up, document battery longevity measures in the medical record as normal and review any impact to device function including measured battery voltage or any unexpected change in battery consumption.
   4. Prompt replacement for devices that reach ERI or EOS unexpectedly or experience one of the clinical impacts listed above commensurate with the patient’s underlying clinical condition.

The ANZCDACC encourage you to report any adverse event or near (potential) adverse event associated with the use of a medical device including any abnormal CIED or lead function. We encourage reporting to ANZCDACC directly via the Committee chair Dr Paul Gould [email protected] and to the following regulators.

In Australia, report to the TGA;

Online

https://www.tga.gov.au/reporting-problems

In New Zealand, report to Medsafe;

Post	Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6145.
Email	[email protected]
Fax	04 819 6806

 

ANZCDACC Hazard Alert June 2022

Device:
Medtronic Cobalt XT™, Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)

TGA Reference: RC-2022-RN-00811-1
Australian Register of Therapeutic Goods (ARTG):
339481, 339482, 339483, 339484, 339485, 339486, 339487, 339488, 339489, 339490, 339491, 339492, 341547, 341548, 341549, 341551, 341552, 341555, 341556, 341557, 341558, 341553, 341550, 341554

Advisory grade TGA: Class I
(Class I recall action occurs when the product deficiency is potentially life-threatening or could cause a serious risk of health).

Description:

In the case where a forementioned ICD/CRTD determines a high-voltage (HV) therapy shock is necessary, there is a potential for this shock to be only ~79% of the programmed energy.

The potential for reduced shock energy is the result of a safety feature, Short Circuit Protection (SCP), that is designed to truncate delivered energy to protect the device when unexpected current is detected during high-voltage (HV) therapy. All Cobalt/Crome devices include the SCP feature. SCP events can trigger during delivery of the HV biphasic waveform in the presence of a lead insulation breach (typically first-phase SCP) or unexpected, additional current in the device HV circuit (typically second-phase SCP).

Analysis of returned devices has confirmed Cobalt/Crome devices can be sensitive to a non-destructive, secondary current pathway involving the HV circuitry. This secondary current does not permanently impair the device’s internal circuitry or battery, but it can result in an electrical switch (that controls current flow during HV delivery) to intermittently remain active for longer than intended after delivery of the first phase of the biphasic waveform. When the secondary current flow through the active switch is detected, the SCP feature truncates delivery of the remaining HV energy.

In Cobalt/Crome devices, an RV Defib lead impedance alert reporting zero (0) ohms will be displayed simultaneous with HV therapy delivery (see example images in the “Presentation” section).
After an SCP event, devices will continue to operate as programmed. Pacing, sensing, episode detection, and anti-tachycardia pacing (ATP) therapies are not impacted by a second-phase SCP event; additionally, HV charging, battery longevity and Bluetooth telemetry are not impacted.

Review of episode data from reported complaints confirms successful delivery of the first-phase energy, and that the second phase of the programmed energy is truncated. When a second-phase SCP event occurs, ~79% of the programmed output is delivered as a monophasic waveform.
Although not observed clinically, HV therapy programmed to the AX>B configuration, or any configuration with Active Can/SVC Coil set to “Can Off,” creates the potential for residual current to flow back to the heart, theoretically resulting in proarrhythmia. Medtronic has confirmed the B>AX configuration (with Active Can On) mitigates the risk for proarrhythmia from this unintended current flow.
Additional analysis has confirmed the switch-mechanism can be intermittent, resulting in HV therapy sequences delivering both the intended full-energy biphasic waveform and/or a reduced-energy monophasic waveform within the same therapy episode. Therefore, programming a 40J output provides the best opportunity to deliver the highest shock energy if the device experiences a second-phase SCP event: in this case, a 32J monophasic waveform will be delivered.

Medtronic has submitted a device software update to address this issue and anticipates it will be available for download into implanted devices beginning third/fourth quarter of calendar year 2022. The update will ensure the full shock energy is delivered in the presence of a secondary, low-level current pathway in the HV circuitry.

Medtronic has not received any reports of permanent harm or death due to this issue.

Based on analysis of peer-reviewed literature as well as CareLink data on shock efficacy from more than 279,000 episodes (Medtronic data on file, May 2022), termination success rates for 32J (~79% of 40J), monophasic shocks versus 40J biphasic shocks are estimated in Table 1. Termination success may vary depending on individual patient risk factors and medication use.

Table 1

	Normal operation (40J, Biphasic energy)	Second-phase SCP (32J, Monophasic delivery)
Estimated First Shock Success* (in VF zone)	89%	85%
Estimated Cumulative Success Shocks 1-6*	99%	98%

Potential harms related to a second-phase SCP event include failure to terminate the arrhythmia due to reduced-delivered-energy, a theoretical risk of proarrhythmia, and complications associated with device replacement, including unnecessary lead replacement due to misinterpretation of the SCP alert.

• While not observed clinically, Medtronic estimates the risk for proarrhythmia is 0.002% in the AX>B configuration, and improbable in the B>AX configuration (less than 0.00004%), with Active Can pathway enabled. These risks may be higher when Active Can is disabled.
• The overall risk for patient mortality due to this issue is estimated to be 0.002% at 24 months when combining the likelihood, a patient will need therapy with the probability an arrhythmia fails to terminate after six sequences of 32J monophasic shocks.
  • Comparatively, the risk of patient mortality due to complications associated with device replacement is 0.032% -0.043% ^1,2,3.

Number of devices affected in Australia and New Zealand:
2979

Presentation:
When a Short Circuit Protection (SCP) event occurs, Cobalt/Crome devices will;

1. Issue an RV Defib lead impedance alert reporting zero (0) ohms that occurs simultaneous with HV therapy delivery (see example images below).
   a. A fixed value of zero (0) ohms indicates that a short circuit was detected during HV therapy delivery.
2. Display the delivered energy of the episode as ~79% of the programmed energy (eg. 31.4J when programmed to 40J).

As a result of the reduced energy delivery, patients are more likely to present with failed and multiple shocks.

Rate of occurrence:
Through 03 June 2022, Medtronic has identified 27 devices (0.03% of devices distributed worldwide) that have experienced a reduced-energy shock, which is accompanied by a Short Circuit Protection (SCP) alert.

While 0.03% has been observed to date, Medtronic projects 0.18% of the ~80,000 distributed devices may experience a second-phase SCP within 24 months of service life, when considering the probability for these SCP events increases overtime, and the likelihood a patient will need HV therapy during that time.

• For the population of patients who received HV therapy, the observed rate was 0.77%. When projecting for this population, the chance of encountering a second-phase SCP event is ~5.0% at 24 months.

Note: The above projections are based on calculations without the planned device software update. Once installed, this update, in addition to the programming recommendations, will resolve occurrences of second-phase SCP events.

Recommendation:

 Each patient requires unique clinical considerations.

1. Until the software update is available, carefully consider the risks versus the benefits of implanting a Medtronic Cobalt XT™, Cobalt™ or Crome™ ICD or CRTD.
2. Prophylactic device replacement is not recommended.
3. Patients programming should be assessed and, if necessary, have their next regularly scheduled follow-up conducted in person to allow for device reprogramming
   a. Consider programming all HV therapy Energy to 40J and Pathway settings to B>AX and Active Can/SVC Coil set with Active Can enabled across all therapy zones.
   b. If the “Get Nominals” feature is used, be aware that AX>B is set pending for Rx5 and Rx6 and should be reprogrammed B>AX.
   c. If a patient requires Active Can be programmed Off, contact Medtronic Technical Services for further guidance.
   d. Ensure the RV Defib Lead Impedance Out of Range alert is enabled (this alert is shipped On with both Device Tone and Wireless CareAlert enabled).
4. Remind patients to contact the clinic if they hear an audible tone coming from their device.
5. Remind patients to keep their home monitor plugged in at all times, or their MyCareLinkHeart™ smartphone app open and active in the background at all times.
6. For patients in whom high DFT is suspected, consider DFT testing to ensure a 10J safety margin exists.
   a. For manually delivered shocks, no episode data is stored, and no CareAlerts are triggered; Review Last HV Therapy values displayed on the Battery and Lead Measurement screen (Data >>Battery and Lead Measurements) to determine if a reduced-energy shock was delivered. If a second-phase SCP occurs during DFT delivery, the device will display ~32J for a 40J programmed output.
   b. Successful delivery of full-energy shocks during manual delivery does not guarantee future delivery of full-energy shocks for spontaneous arrhythmias.
7. If an RV Defib lead impedance alert reporting zero (0) ohms is observed, this is evidence that an SCP event has occurred. Contact Your Local Medtronic Representative for confirmation on the source of the impedance alert.
   a. A Save-Session file or a CareLink transmission file will be requested; Medtronic Technical Services can use stored device information to confirm whether the SCP event is due to a suspected lead issue, or due to unexpected current in the HV circuit.
   b. If the delivered energy during the episode is ~79% of the programmed energy AND the SCP alert indicates an RV Defib Lead impedance alert reporting exactly zero (0) ohms, this is an indication of a second-phase SCP event and not a lead issue.
8. After confirming the cause of the RV Defib Lead Impedance alert with Medtronic Technical Services:
   a. Consider device replacement commensurate with the patient’s underlying health and history, with the understanding a device has an ~81% probability of delivering subsequent reduced-energy shocks, and with the understanding an update for implanted devices is anticipated to be available beginning third quarter/fourth quarter of calendar year 2022.
   b. If the device remains implanted, ensure all HV therapy sequences, programmed parameter settings and SVC Coil pathway (where appropriate) are as desired following any lead replacement.

References:

1. Tarakji KG, et al. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. The New England Journal of Medicine. 2019;380(20):1895-1905.
2. Medtronic Data on File. MDT2260884-CRHF CIED Infection Report; Agile: MDT2260884, Version 2.0, 11/02/2015.
3. Birnie D, et al. Complications associated with defibrillation threshold testing: The Canadian experience. Heart Rhythm. 2008; 5(3):387-90.

The ANZCDACC encourage you to report any adverse event or near (potential) adverse event associated with the use of a medical device including any abnormal CIED or lead function. We encourage reporting to ANZCDACC directly via the Committee chair Dr Paul Gould [email protected] and to the following regulators.

 In Australia, report to the TGA;

Online

https://www.tga.gov.au/reporting-problems

In New Zealand, report to Medsafe;

Post	Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6145.
Email	[email protected]
Fax	04 819 6806

 

ANZCDACC Product Hazard Alert August 2022

Device: 

A SUBSET OF ASSURITY™, ENDURITY™ AND ZENEX™ PACEMAKERS MODELS PM2162, PM2172, PM2272, PM2282*
* TGA Approved but not currently commercially released
TGA Reference: 
RC-2022-RN-01000-1

Australian Register of Therapeutic Goods (ARTG): 
267517, 267514, 267513, 322001*
* TGA Approved but not currently commercially released

Wand Notification Reference:
Not supplied by Abbott

Advisory grade TGA: 
Class I
(Class I recall action occurs when there is a reasonable probability that the use of or exposure to, the deficient therapeutic goods will cause serious adverse health consequences)

Description: 
A manufacturing laser surface preparation subprocess, unique to a single assembly line in Malaysia subject to process variation, may not have properly prepared the device’s metal housing potentially leading to abnormal device-to-header adhesion.

This in turn may allow moisture ingress into the pulse generator header.

This specific manufacturing process is no longer in use.

Based on data reviews, the functionality interruption may occur as soon as within a week from the last transmission date in Merlin.net.

Number of devices affected in Australia and New Zealand: 
2211

Presentation: 

The current reported clinical impact has included loss of pacing, reduced battery longevity, devices reverting to back-up mode, and/or loss of telemetry / communication. There have been no deaths to date.

Rate of occurrence: 

To date, one hundred twenty-eight (128) complaints have been identified from approximately 83,000 specific serial numbers potentially susceptible to this issue. Functionality interruption was noticed on average after 749 days (~2.1 years) of implant duration. An overall rate of 0.15% loss of device function

Recommendation: 

• Prophylactic generator replacement is NOT generally recommended.
• Assess each patient’s risk. Consider individualised therapy up to and including generator replacement for patients who are at high risk if interruption of pacemaker function were to occur. Factors to be considered include:
  • Adequacy of intrinsic / underlying rhythm
  • Individual patient characteristics and circumstance, including access to emergency care
  • Ability to adequately monitor patients based on risk
• When possible, monitor patients using Merlin.net to benefit from compliance and alert monitoring, including Electronics Performance Indicator (EPI – see description below), between routine device checks.
• For patients enrolled in Merlin.net;
  • Remind them of the importance of using remote monitoring.
  • Consider reducing the “Disconnected Transmitter Thresholds” in the patient’s profile to allow earlier notification of disconnected monitors. Promptly address disconnected monitors or DirectAlert™ Check status if they arise.
• Prompt replacement for devices that receive an EPI notification, reach ERI, or experience one of the clinical impacts listed above, unless particular patient circumstances preclude this.
• Ensure your clinic contact information in Merlin.net is current.

EPI (Electronics Performance Indicator) Description: The EPI tool assists in patient management in patients followed with Merlin.net. The EPI tool supplements ERI using data available on Merlin.net to identify abnormal electrical system behaviour resulting from loss of hermeticity. The EPI tool is an Abbott surveillance process that reviews data from all devices within this affected population communicating with Merlin.net. If an EPI signal is detected, Abbott will notify the clinic using the email contact information in Merlin.net.

The ANZCDACC encourage you to report any adverse event or near (potential) adverse event associated with the use of a medical device including any abnormal CIED or lead function. We encourage reporting to ANZCDACC directly via the Committee chair Dr Paul Gould [email protected] and to the following regulators. 

In Australia, report to the TGA;

Online

https://www.tga.gov.au/reporting-problems

In New Zealand, report to Medsafe;

Post	Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6145.
Email	[email protected]
Fax	04 819 6806

 

ANZCDACC Implant Hazard Alert June 2021

Device: Boston Scientific dual chamber INGENIO family pacemakers and Cardiac resynchronisation (CRTPs).

Models: ADVANTIO DR EL (K084, K087), INGENIO DR EL (K184, K187), VITALIO DR EL (K287), INVIVE CRT-P (V182, V183)

 TGA Reference: RC-2021-RN-01305-1

Australian Register of Therapeutic Goods (ARTG): 194925, 194926, 194927, 202980, 202981, 202982, 213922, 213923, 213924, 213925, 213926, 213927, 194920, 194921, 194924, 202999, 203000, 203004, 213930, 213931, 194928 and 194929

Advisory grade TGA: Class I

(Class I recall action occurs when the product deficiency is potentially life-threatening or could cause a serious risk of health).

ANZDACC Advisory Grade: Semi-urgent

Device:

Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)

 TGA Reference:

Australian Register of Therapeutic Goods (ARTG):
339481, 339482, 339483, 339484, 339485, 339486, 339487, 339488, 339489, 339490, 339491, 339492, 341547, 341548, 341549, 341551, 341552, 341555, 341556, 341557, 341558, 341553, 341550, 341554

Wand Notification:
200109-WAND-6TXFRQ, 200109-WAND-6TXFSH, 200109-WAND-6TXFVH, 200109-WAND-6TXFTE, 200109-WAND-6TXFTX, 200109-WAND-6TXG78, 200109-WAND-6TXFST, 200109-WAND-6TXFU9, 200109-WAND-6TXFT3, 200109-WAND-6TXG6G, 200109-WAND-6TXFTO, 200109-WAND-6TXG7J, 200109-WAND-6TXFPN, 200109-WAND-6TXFO3, 200109-WAND-6TXFJ5, 200109-WAND-6TXFOK, 200109-WAND-6TXFQB, 200109-WAND-6TXFQ1, 200109-WAND-6TXFOZ, 200109-WAND-6TXFP9, 200109-WAND-6TXFQO, 200109-WAND-6TXFN0, 200109-WAND-6TXFKX, 200109-WAND-6TXFNA

Advisory grade TGA:

Class II
(Class II recall action occurs when the product deficiency could cause illness, injury or result in mistreatment, but are not class I.)

ANZCDACC Product Defect Correction Notification

Device:

Merlin™ Patient Care System (PCS) Software Model 3330 v25.0.X–v25.3.X

GTIN 05414734509725

When used with

Abbott Gallant™, Neutrino™ NxT, Entrant™ devices

Note:

1. In Australia; Neutrino™ NxT and Entrant ™ are currently approved but not commercially launched (Only Gallant is commercially available).
2. In New Zealand; Only Gallant and Entrant are Medsafe WAND notified however only Entrant has been commercially launched at limited accounts.

 TGA Reference:

Australian Register of Therapeutic Goods (ARTG):

124262

Advisory grade TGA:

Class II

Class II- A situation in which use of, or exposure to, the deficient therapeutic good(s) may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Device:
All Medtronic Cobalt™ and Crome™ ICDs and CRTDs. Namely:
Cobalt™:
Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DDPA2D4; Cobalt DR: DDPB3D1, DDPB3D4; Cobalt XT HF: DTPA2D4, DTPA2D1; Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1; Cobalt HF: DTPB2D4, DTPB2D1; Cobalt HF Quad: DTPB2QQ, DTPB2Q1
Crome™:
Crome VR: DVPC3D1, DVPC3D4; Crome DR: DDPC3D1, DDPC3D4; Crome HF: DTPC2D4, DTPC2D1; Crome HF Quad: DTPC2QQ, DTPC2Q1

TGA /Medsafe Reference:
Australian Register of Therapeutic Goods (ARTG): 313620
Medsafe Reference: 28468

Advisory grade TGA:
Not listed on TGA website but likely Class II
(Class II recall action occurs when the product deficiency could cause illness, injury or result in mistreatment, but are not class I.)

ANZDACC Advisory Grade: Routine

ANZCDACC Product Defect Correction and Implant Hazard Alert June 2021

Device: Medtronic Reveal LINQ with TruRhythm Cardiac Monitoring Systems

 TGA Reference: RC-2021-RN-01276-1

Australian Register of Therapeutic Goods (ARTG): 218791

Advisory grade TGA: Class II

(Class II recall action occurs when the product deficiency could cause illness, injury or result in mistreatment, but are not class I.)

ANZDACC Advisory Grade: Routine

ANZCDACC Safety Alert Notice March 21^st 2021

Device:

Subset Biontronik Ilesto, Inventra, Iperia, Itrevia, Ilivia, Intica, Intica Neo ICDs and CRT-D implanted since 2013

TGA Reference: RC-2021-RN-00667-1

Advisory grade TGA:  Class I

(Class I recall action occurs when the product deficiency is potentially life threatening or could cause serious risk to health)

ANZDACC Advisory Grade: Routine

Number of CIEDs affected in Australia and New Zealand:

Australia Approximately  2000

New Zealand Approximately 500