| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01316-1 |
| Product Name/Description |
Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra
(Implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices)
Multiple model numbers |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
St. Jude Medical (SJM) is notifying physicians of the risk of premature battery depletion associated with their ICDs and CRT-Ds manufactured before May 23, 2015. High voltage ICDs and CRT-Ds that utilise Lithium-based battery chemistries are subject to Lithium cluster formation during high voltage charging. Depending on their location, Lithium clusters may cause a short circuit that can lead to premature battery depletion. If a short circuit occurs, battery depletion can occur in these devices within a day to a few weeks, which may result in the inability to deliver therapy.
Among 398,740 devices sold worldwide, 841 devices returned for analysis due to premature battery depletion have had evidence of lithium material in the form of “clusters” in the battery. Forty-six (46) exhibited visible clusters bridging the cathode and anode causing shorting. There have been 2 deaths that have been associated with the loss of defibrillation therapy as a result of premature battery depletion. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
SJM is contacting physicians to provide details regarding risk and patient management recommendations. Premature battery depletion can be identified by physicians through remote monitoring or in person visits showing ERI or more advanced battery depletion.Patients may become aware when their device reaches ERI because they may feel a vibratory patient notifier alert.SJM is providing recommendations that include confirming patients can feel and recognise vibratory alerts and reaffirming the availability and usage of remote monitoring to avoid or minimise time without device therapy for bradycardia and tachycardia events. Prophylactic device replacement is not recommended because complications following replacement have been reported to occur at a greater rate than the rate of harm associated with premature battery depletion. SJM is also notifying doctors not to implant any unused affected devices that they may have in their inventory.These devices will be replaced by unaffected stock. This action has been closed-out on 17/05/2017. |
| Contact Information |
02 9936 1211 - St Jude Medical |