| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01460-1 |
| Product Name/Description |
Nanostim Leadless Cardiac Pacemaker (LCP)
Model Number: S1DLCP
Supplied in Australia under Clinical Trial Notification (CTN) scheme |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
St Jude Medical (SJM) has identified that patients with Nanostim leadless cardiac pacemakers may experience loss of telemetry and pacing due to battery malfunction. Investigation by SJM found decreased battery capacity due to reduced electrolyte, resulting in high internal battery resistance. This disrupts the required capacity for proper device function and reduces device longevity. There have been seven (7) reports worldwide of lost telemetry and pacing output as a result of a battery malfunction. Battery malfunction may be indicated with a loss of telemetry/communication with the implanted device and/or loss of pacing and magnet mode operation. These events occurred between 29 and 37 months post implant. No patient injuries have been reported in association with the loss of bradycardia pacing therapy. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
St Jude Medical has contacted the cardiologists who have implanted Nanostim leadless cardiac pacemakers providing further information about the above issue including patient management recommendations. They have been instructed to stop implanting these devices into new patients. For more information, please refer to https://www.tga.gov.au/alert/nanostim-leadless-cardiac-pacemaker . This action has been closed-out on 15/05/2017 |
| Contact Information |
02 9936 1235 – St Jude Medical Australia Pty Ltd |