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.
Device: All models of RF enabled St. Jude Medical Implantable Cardioverter Defibrillators (Ellipse Fortify Assura, Unify Assura, and Quadra Assura) and Pacemakers (Assurity and Allure) when used with Merlin@home RF Remote Monitor Model EX1150.