| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00906-1 |
| Product Name/Description |
COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioveter-Defibrillators (ICDs)
Affected model numbers:
COGNIS CRT-D : N106, N107, N118, N119, P106, P107
TELIGEN DR ICD: E110, F110
TELIGEN VR ICD: E102, F102
Manufactured prior to December 2009
ARTG Numbers: 154034, 154033, 154039 & 154037 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific has determined that the performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009 may be compromised over time, causing increased current drain that can lead to premature battery depletion. All cases reported to date have been detected by diagnostic tools within Boston Scientific’s Safety Architecture before device function was compromised. “Safety Architecture” refers to a set of diagnostic monitoring which periodically assess device performance, including battery voltage, power consumption, and charge time, and have proven effective in identifying instances of unexpected battery use (via programmer alert screens or replacement indicators) before therapy becomes unavailable. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
There are no additional clinical recommendations beyond the current standard of patient care and normal device monitoring.
- Remind patients to contact the clinic if beeping is heard from their device, as instructed in the patient manual.
- Physicians should promptly investigate alerts and unanticipated replacement indicator messages.
- Following a Safety Architecture alert, contact Boston Scientific Technical Services as directed on programmer screens [24 hours per day / 7 days per week]. Technical Services can facilitate an evaluation of “save-to-disk” information (while the device is still implanted) to help clarify available replacement time. For more details, see http://www.tga.gov.au/safety/alerts-device-cognis-crt-d-and-teligen-icd-130903.htm . |
| Contact Information |
02 8063 8299 - Boston Scientific Technical Services |