| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01011-1 |
| Product Name/Description |
COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioverter -Defibrillators (ICDs)
Affected model numbers:
COGNIS CRT-D : N106/N107/N108/N118/N119/N120/P106/P107/P108
TELIGEN DR ICD:E110/E111/F110/F111
TELIGEN VR ICD: E102/E103/F102/F103
Devices manufactured prior to March of 2010.
ARTG Numbers: 154039, 154037, 154034, 154033, 154035, 154038, 154036 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
This is an update to the August 2013 physician communication (TGA Ref.: RC-2013-RN-00906-1). The performance of an LV capacitor may be compromised in some devices after two or more years of implant time, which will increase battery use and may eventually initiate one or more Safety Architecture alerts and patient-audible beeping. The most common alert is a yellow programmer screen that states, “Voltage is too low for projected remaining capacity. Contact Technical Services with Code 1003”. LATITUDE issues a corresponding yellow alert (nominally configured “On”). In other instances, diminished LV capacitor performance can result in an early “Explant” battery status indicator (ERI) and a replacement window that may be less than 3 months.
Boston Scientific has identified a second subset of devices that may exhibit a similar issue. No patient deaths have been associated with this issue. Affected devices have not been available for implant for more than three years. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Boston Scientific has recently introduced updated software that will further improve Safety Architecture effectiveness. Boston scientific recommend that patients with a device in the affected population be scheduled for an in-clinic visit to upgrade their device with this new software. After a device has been upgraded, continue normal device monitoring as directed within labelling, and promptly investigate all alerts and device beeping.
Devices that experience a low voltage alert require replacement. If not replaced, increased current drain could deplete the battery and impact therapy delivery and telemetry. If a Safety Architecture alert is observed, Boston Scientific Technical Services can analyse device information downloaded from a recent in-clinic or LATITUDE interrogation, which will clarify approximately how much time is available to replace the device.
Fro more details, please see http://www.tga.gov.au/safety/alerts-device-cognis-crt-d-and-teligen-icd-130924.htm . This action has been closed-out on 07/07/2016. |
| Contact Information |
02 8063 8239 - Boston Scientific Technical Services |