| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01122-1 |
| Product Name/Description |
Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra devices
(Implantable cardiac defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices)
Manufactured between January 2010 and May 2015
Fortify VR
Fortify ST VR
Fortify Assura VR
Fortify DR
Fortify ST DR
Fortify Assura DR
Unify
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Multiple Models
Multiple ARTG Numbers |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
St Jude Medical (SJM) is providing additional information following on from the previous notification in October 2016 (RC-2016-RN-01316-1).
Previously there was no method to identify devices subject to premature battery depletion prior to reaching the ERI voltage. SJM have developed Battery Performance Alert (BPA) for patients who have Impacted Devices.
The BPA will provide notification of abnormal battery performance prior to premature battery depletion, & before ERI voltage. Battery information is uploaded nightly to Merlin.net where the most recent 32 days of data are analysed each day to determine any anomalous battery voltage trend. Once the BPA is triggered, notification is provided to physicians through Merlin.net and the Merlin programmer during routine follow-up evaluations. For patients not followed remotely with Merlin.net, the status of their battery/whether the BPA has triggered an alert can only be determined with in-person interrogation using the Merlin programmer. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
St Jude Medical is advising customers:
1. Do not implant unused affected devices.
2. Conduct patient follow-up per standard practice.
3. 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 due to lithium cluster induced shorts.
4. In the event of a BPA or ERI indicator in these devices, immediate device change is recommended. (Updated recommendation)
5. Follow directions in the customer letter regarding battery monitoring in patients of already-implanted devices.
This action has been closed out on 18/02/2019 |
| Contact Information |
1800 839 259 - St Jude Medical |