| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01108-1 |
| Product Name/Description |
InSync III Cardiac Resynchronisation Therapy Pacemakers (CRT-P)
Models 8042, 8042B, 8042U
Previous ARTG Number: 132030 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
There is an issue with InSync III CRT-Ps related to long-term battery performance because of unexpected high battery impedance. Unexpected high battery impedance can result in the battery’s inability to supply sufficient electrical current, impacting device function. If pacing capture is compromised, some patients may experience a return of heart failure symptoms due to loss of biventricular pacing. In cases involving pacemaker-dependent patients, a loss of pacing capture could result in serious injury or death. InSync III CRT-pacemakers are no longer distributed. Current devices have a modified battery design that is not susceptible to this issue.
Through 27 October 2015, the events have occurred in devices with implant durations of 53 months or more. Medtronic's modelling predicts an estimated failure rate between 0.16% and 0.6%. There is no provocative testing that can predict which specific devices may fail, and there is no programming that can mitigate this issue. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Medtronic is issuing following recommendations to cardiologists and surgeons for managing patients with an InSync III CRT-pacemaker:
- Prophylactic device replacement in non-pacemaker-dependent patients is not recommended.
- For pacemaker-dependent patients, physicians should carefully weigh the risks and benefits of device replacement to mitigate this issue on an individual patient basis. The estimated per patient mortality risk of this issue (0.007% to 0.02%) is comparable to the estimated per patient mortality risk of complications associated with an incremental, early device replacement (0.005%).
- Continue routine patient follow up in accordance with standard practice, and advise patients to seek medical attention immediately if they experience new or unexpected symptoms.
Medtronic is also including a draft patient letter for cardiologists and surgeons to contact their patient about this matter. Also, Medtronic is offering a supplemental device warranty.
For further information please see https://www.tga.gov.au/alert/insync-iii-cardiac-resynchronisation-therapy-pacemakers . This action has been closed-out on 20/04/2017. |
| Contact Information |
(02)9857 9094 - Medtronic |