Device: LivaNova (Formerly Sorin Group) Platinium ICDs and CRTDs
TGA Reference: RC-2017-RN-00913-1
Advisory grade TGA: TBA
ANZDACC Advisory Grade: Routine
Description: There are 2 issues in this advisory which are as follows;
- An electronic component used in a specific hardware version of Platinium devices has been found to be sensitive to electrostatic discharge (ESD) potentially generated during the implant surgery. The discharge can trigger overconsumption of current, leading to reduced device longevity (5% longevity loss per month). The overconsumption is detectable upon interrogation of the device during follow-up visit and it can be stopped if the device is reset in clinic by a LivaNova representative. Although the overconsumption is stopped after this reset, the residual longevity displayed by the programmer may temporarily be underestimated.
- If a device is exposed to a MRI’s magnetic field, overconsumption can occur and the battery voltage will decrease to 2.80V. At this level, the device remaining longevity is 25% of the initial longevity.
Neither of the issues described above affect the therapeutic functions of the device. All sensing, pacing and shock delivery capabilities will remain functional.
Since 18th of May 2017 Livanova has stopped releasing the devices which are potentially affected and Platinium devices with a new version of this electronic component have been made available.
A software patch has been created and has either been uploaded to programmers or in the process of being uploaded. Devices are automatically upgraded upon device interrogation. This patch is reported to eliminate the risk of premature battery depletion as a result of an MRI scan. The patch does not however eliminate the risk premature battery depletion as a result of ESD if this occurs.
Risk: No permanent injury or death has occurred as a result of these issues.
As of 16th of June 2017 there have been 18 reports of overconsumption associated with ESD exposure at implant (0.19% of alert devices).
There are 4 reports attributed to MRI scans. It was not reported however how many patients with the alert devices had MRI scans so an accurate risk cannot be calculated. All 4 cases reported after MRI led to premature device replacement. 1 of these patients reported feeling a sensation of heat in the area of the device.
Number of devices affected in Australia and New Zealand: 8 devices affected in Australia and 0 in New Zealand. All the implanting physicians of these affected devices have been made aware of the issues and all devices are accounted for.
Presentation: Upon interrogation of the affected device, the warning “(A3) Technical issue” is displayed.
- Standard follow up as per physician routine practice (increased follow up is not recommended)
- If the “(A3) Technical issue” is displayed, contact your LivaNova representative who will organise the reset of the device. A second reset may be necessary in order to correct the estimation of the residual longevity displayed by the programmer.
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 firstname.lastname@example.org and to the following regulators.
In Australia, report to the TGA;
In New Zealand, report to Medsafe;
||Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6145.
||04 819 6806
Device: EMBLEMTM S-ICDs (Models A209 and A219) and SQ-RXTM S-ICDs (Model 1010)
TGA Ref: RC-2017-RN-00830-1
Advisory Grade TGA: TBA
ANZDACC Advisory Grade: Routine
Description: Environmental radiation corrupting S-ICD device memory causing delivery of atypical energy (similar to arrhythmia induction) and disabling of tachycardia therapies in a patient with a S-ICD. This resulted in induction of VF and contributed to the patient’s death. Laboratory testing by Boston Scientific engineers identified that this event could be reproduced by corrupting two specific adjacent bits of device memory in the S-ICD. It was determined by the Boston scientific engineers that the corruption was a result of an event known as a single event upset (SEU). A SEU is a change in the state of device memory induced by environmental radiation effecting a specific memory location. The patient in question did not have any additional exposure to radiation (eg ionizing radiation therapy).
Risk: This is an isolated event it had occurred in 1 of 37 000 S-ICD’s distributed worldwide. Due to being an isolated event it is difficult to confidently predict the overall risk, however based on available data the risk of occurrence is estimated at 1 in 300 000 over 5 years.
Number of devices affected in Australia and New Zealand:
Presentation: Currently only one device has been affected worldwide which resulted in sudden death due to arrhythmia induction and deactivation of tachycardia therapies.
Advice: In considering the following advice the recommendations related to the Advisory notice titled: Boston Scientific Model 3200 S-ICD Programmer posted on the ANZDACC website on the 27th of January needs to be taken into consideration.
The memory corruption is undetectable with integration with the Subcutaneous ICD therefore the following is recommended.
- Standard inpatient follow as per physician routine practice (increased follow up is not recommended)
- Continue latitude (remote monitoring) as normal
- Follow precautions with radiation therapy as described in S-ICD manual.
- Prophylactic S-ICD replacement is not recommended.
Boston scientific is developing a software upgrade to correct the issue and is expected to be submitted to the TGA in July 2017. Until this is available this alert should be considered when assessing the risk vs benefits of the S-ICD for each patient.
ANZCDACC Advisory Notice 24th May 2017
Device: LivaNova Ovatio, Paradym RF and Intensia ICD’s and CRT’s
TGA Ref: RC-2017-RN-004393-1
Advisory Grade TGA: Class II Recall
ANZDACC Advisory Grade: Routine
Description: Undetectable battery depletion in the event of recurrent shocks or capacitor charge due to defibrillator lead issue/failure (over sensing, disconnected or broken defibrillator leads) where an intervention is planned on the defibrillator lead within 24 hours.
Risk: Can occur in any of the above mentioned devices where battery function is checked within 24 hours of recurrent shock capacitor charges in the event of defibrillator lead issue/failure.
Number of devices affected in Australia and New Zealand: TBA in Australia Zero in New Zealand: not supplied.
Presentation: Patient’s that have recurrent shock capacitor charges (due to defibrillator lead issue/failure) with the affected device are at risk of unreliable battery assessment. Battery measurements within 24 hours of last capacitor charge will not be updated and therefore may be inaccurate resulting in failure of detection of RRT status. Battery status is updated 24 hours after last shock capacitor charge and will represent accurate battery measurement. Lead integrity alerts and lead over sensing episodes are indicative of patients at risk recurrent shock capacitor charges and as such at risk of this advisory.
Advice: Patient’s that present with either appropriate or inappropriate recurrent shock capacitor charges who have a device interrogation within 24 hours of the last capacitor charge must have an additional integration 24 hours after the last capacitor charge to ensure accurate battery estimate.
For patients that present with lead integrity issues and recurrent shock capacitor charge requiring lead revision, it is recommended that the ICD tachycardia therapies are deactivated and the patient externally monitored 24 hours prior to intervention with revaluation of battery status after the 24 hour period has elapsed, and prior to lead revision to confirm battery status.
Where lead intervention is required before 24 hours of last shock capacitor charge then the physician should consider prophylactic ICD generator change at time of lead revision. In this situation if the ICD generator is not changed then the patient will require a device interrogation 24 hours after last shock capacitor charge.
Devices that do not have recurrent shock capacitor charges do not require any intervention or increased follow up. These should undergo usual clinical follow-up.
ANZCDACC Advisory Notice 20th January 2017
Device: Boston Scientific Model 3200 S-ICD Programmer
Advisory Grade TGA: TBA (?Hazard Alert (Recall for product correction))
ANZDACC Advisory Grade: Routine
Description: Potential RF interference during programmer interrogation of S-ICD with potential to cause temporary and/or permanent unintended programming changes. Latitude remote monitoring not affected.
Ten observations of unintended programming have been reported.
One inappropriate shock and therapy programmed off in another device. One device returned to nominal factory settings.
Risk: Overall risk of adverse event is calculated at 1/25,000 in 5 years for EMBLEM devices and 1/200,000 in 5 years for SQ-RX devices.
In Australia there are 385 devices affected and New Zealand 93 devices.
Presentation: Patients with inappropriate shocks, failure to deliver therapy due to unintended programming (therapies off), unexpected programming changes on home monitoring or at routine review.
Advice: A software update will be released at a future date to rectify this issue. Home monitoring is recommended and if a programmer needs to be used that the device should be reinterrogated immediately after ending session to ensure that there hasn’t been any unintended programming.
Use remote monitoring for routine follow up where ever possible. Reduce frequency of in clinic checks while following medical society guidelines.
Do not leave patient unattended in clinic while an active telemetry session is in progress. Ensure external defibrillation equipment and appropriately trained staff are readily available during in office follow up.
Minimize duration of programmer communication and end telemetry session promptly.
Contact Boston Scientific technical services for assistance should unintended programming occur.
Device: Medtronic Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™ Cardiac Resynchronization Therapy Defibrillators (CRT-D) Models DTMB2D1 DTMB2D4 DTMB2QQ DTMA2D1 DTMA2Q1 DTMA2QQ DTMA2D4
Advisory Grade TGA: Hazard Alert (Recall for product correction)
ANZDACC Advisory Grade: Routine
Number at risk in Australia 10 devices and New Zealand 26 devices
Risk: A device software issue that may occur with the above models which may lead to loss of LV pacing with a particular sequence of programming. The result is RV pacing only and potentially worsening heart failure. As of 10th November 2016, Medtronic reports two “non-critical” events related to this issue. A review of Medtronic’s available data reveals an overall occurrence rate of 0.38%.
Description: This software issue leading to loss of LV pacing occurs when devices are programmed from Managed Ventricular Pacing (MVP) mode to a pacing mode with AdaptivCRT™ enabled. The LV pacing part is not activated despite the device indicating it is.
Presentation: Patients experiencing loss of left ventricular pacing can present with heart failure symptoms or worsening heart failure.
Advice: A software update will be released at a future date to rectify this issue. Otherwise until then routine follow-up is recommended (Home Monitoring where appropriate could also be utilised) and at this follow-up it is important to establish that LV pacing is occurring:
The following programming and assessment is suggested by Medtronic
If the CRT setting is currently programmed to Adaptive Bi-V and LV or Adaptive Bi-V, review rate histogram CRT Pacing percentages (CRT Pacing: Bi-V and LV).
If Bi-V and LV pacing percentages Since Last Session are both near 0%, then the device has encountered the programming sequence and has lost LV pacing. Then it is suggested to perform the following programming steps to restore the device to its expected operating state with AdaptivCRT enabled: Select the CRT parameter window, select Nonadaptive CRT, and select PROGRAM. Select the CRT parameter window, select the desired AdaptivCRT setting (Adaptive Bi-V and LV or Adaptive Bi-V), and select PROGRAM
ANZCDACC – Advisory Notice: 1 November 2016
Device: LivaNova Field Safety Notice Applicable to REPLY Models D, DR, VDR, SR ESPRIT Models D, DR, S, SR, FACIL Model DR pacemakers
ANZCDACC Advisory Notice 30 August 2016
Device: Medtronic Viva Cardiac Resynchronisation Therapy Defibrillators and Evera Implantable Cardioverter Defibrillators
Note: The advisory has only been issued for one particular batch of these generators consisting of 78 devices worldwide. No other Viva or Evera devices are affected.
ANZCDACC Advisory Notice 7 March 2016
Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM) Model LNQ11 8042, 8042B, 8042U
ANZCDACC Advisory Notice 25 November 2015
Device: Medtronic InSync III Cardiac Resynchronization Therapy Pacemakers (CRT-P) Models 8042, 8042B, 8042U
24 November Addendum to ANZCDACC Advisory Notice 12 November 2015
Device: St Jude Optisure Dual Coil Defibrillation Leads