| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00034-1 |
| Product Name/Description |
St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev. 0
Affected ICD/CRT-D devices: Current/Promote/AnalyST, Unify/Fortify, Assura and Ellipse families
Multiple ARTG numbers for ICD/CRT-D devices
ARTG number for the Merlin Programmer: 124262 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
When using the Merlin Programmer with software version17.2.2 as part of a single VF detection zone configuration for ICD/CRT-D devices, the sinus redetection value will be inappropriately set to zero milliseconds. As a result, any intrinsic activity following the first shock will be considered a “sinus rate” and the device will diagnose “return to sinus”. Therefore, if the arrhythmia was not terminated by the initial high voltage therapy, the ongoing arrhythmia would be considered a new episode causing the next high voltage therapy to also be delivered at the first programmed energy level. For example, if the first shock is programmed to 20 joules and subsequent shocks are programmed to higher energy values, the only HV therapy the patient would receive if the arrhythmia continues and is redetected, would be 20 joules, rather than the increasing HV energy levels as programmed. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Clinicians are advised to review their SJM ICD/CRT-D patient records for patients with affected devices implanted or seen in clinic starting in September 2013 and programmed to a single VF detection zone with the 17.2.2 software. For patients identified during this review St. Jude is recommending to immediately schedule a follow-up visit. For patient devices programmed with 17.2.2 software, a new software version 17.2.3 will correct this issue and is expected to be available by February 2014. Using this software, programming any parameter will reset the return to sinus criteria to normal function. If a patient is seen before the 17.2.3 software is installed, then program the device to a two or three zone configuration, even if one of the zones is strictly a monitor zone. This will resolve the issue when using a programmer with 17.2.2 software. For more details, please see http://www.tga.gov.au/safety/alerts-device-st-jude-medical-icd-crtd-140128.htm . This action has been closed-out on 29/01/2016. |
| Contact Information |
02 9936 1215 - St Jude Medical Australia |