| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01402-1 |
| Product Name/Description |
Medtronic Model 37751 Recharger, in Charging Systems used with implantable neurostimulators (INS)
Charging System Models 37754 & 97754, used with spinal cord stimulation (SCS) devices:
- Restore
- RestoreUltra
- RestoreAdvanced
- RestoreSensor
- RestoreUltra SureScan MRI
- RestoreAdvanved SureScan MRI
- RestoreSensor SureScan MRI
Recharger in Charging System kit Model 37651, used with deep brain stimulation (DBS) device:
- Medtronic Activa RC
ARTG Number: 121279 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified an increase in customer complaints about Rechargers in an unresponsive error state, where the Recharger is non-functional with a blank screen & beeping every 5 seconds. Rechargers manufactured since November 2014 (serial # starting “NKA4” or “NKU4”) are more susceptible, with reports for 2% of these Rechargers & 0.2% for those manufactured before November 2014. When the error occurs, the Recharger is unable to recharge the neurostimulator until the Recharger is reset. If the neurostimulator battery is allowed to become fully depleted, this can lead to loss of therapy and return of baseline pain levels and associated disease-specific symptoms. If the battery is allowed to remain fully depleted, it may over-discharge, affecting the battery capacity and the recharge frequency. For a subset of patients receiving DBS therapy, in rare instances, a loss of DBS therapy may result in a life threatening injury or death however no reports of this kind have been received. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic is working on a permanent solution, in the interim there are the following workarounds:
1. To prevent the unresponsive error state, the Recharger should be plugged into the AC power supply (aligning white triangles) prior to starting a recharging session of the neurostimulator & remain connected to the AC power supply until the recharging has finished. NB: The AC power supply does not need to be plugged into a power outlet if the Recharger is charged.
2. To restore Recharger functionality if the unresponsive error occurs, patients can contact Medtronic Neuromodulation on 1800 652 972 / Customer Service on 1800 668 670 for instructions on resetting the unresponsive Recharger.
Treating physicians will be provided with illustrated reset instructions with the customer letter. Patients should contact their physician immediately if they experience a return of symptoms. NB: This issue can recur after reset if the recharging instructions in point 1 are not completely followed.
This action has been closed out on 26/09/2018 |
| Contact Information |
1800 668 670 - Medtronic Australasia Customer Service |