| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00322-1 |
| Product Name/Description |
SJM Confirm External Patient Activator Model DM2100A
Supplied separately or together with a SJM Confirm Implantable Cardiac Monitor (ICM) DM2100 or DM2102.
ARTG Numbers: 160466 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
15/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
St. Jude Medical's (SJM) data shows that two specific lots of batteries used to power the DM2100A Activators may exhibit faster than normal battery depletion. DM2100A activators with batteries from affected lots may exhibit faster than normal low battery status, identified by emitting one low-pitched audible tone and flashing red lights for 9-10 seconds once every hour, or immediately when a button is pressed. Additionally, in the event that an activator button is pressed and there is no indication of lights or tones, this is an indication of a depleted battery.
|
| Recall Action |
Recall |
| Recall Action Instructions |
If an activator exhibits any of the above referenced issues, consumers and clinicians are asked to notify their local St. Jude Medical representative and the representative will provide a replacement activator at no cost. |
| Contact Information |
03 9936 1215 - St Jude Medical Therapy Development |