| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00289-1 |
| Product Name/Description |
Brain and Spinal Cord Stimulators
Multiple model numbers affected
ARTG Numbers: 160118, 160117, 188274, 188034, 141861, 154866, 177594, 141860, 215748, 215749, 215750 and 215751 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Cycling is a programmable feature which allows the stimulation output of a device to toggle on and off based on programmed settings. Enabling cycling at certain parameter settings may decrease the recharge interval for rechargeable devices and the device longevity.
In May 2012, the first two cases of premature battery depletion where cycling was programmed at fast rates (0.1s ON/OFF) in conjunction with low patient amplitudes (<3 Volts) were reported. Both of these reports involved the PrimeADVANCED device Model 37702. Both devices were explanted, returned and analysed. This inspection, engineering bench testing, and detailed understanding of how the patients used these devices confirmed that specific patient therapy parameters in conjunction with cycling being enabled resulted in a higher current drain on the battery when compared to running the device in continuous mode. Higher current drain results in reduced battery longevity. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Surgeons are advised that the updated calculations and graphs available at professional.medtronic.com/cycling to assess the affect of cycling on device longevity. Surgeons are requested to remind their patients to continue to check battery status. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-neurostimulation-140317.htm . |
| Contact Information |
1800 668 670 - Medtronic Australasia Pty Ltd |