CanadaThe Medtronic Restore Clinician Programmer Application (model A71100) used to program the Restore family of spinal cord stimulation implantable neurostimulators (INS) is affected; affected units have lot/serial numbers with more than 10 numbers—contact the manufacturer to identify yours. Medtronic is notifying consignees because a software issue may prevent clearing a device reset message, which can stop therapy and cause recurrence of the patient’s pain and may require surgical replacement of the INS to resume therapy. Contact the manufacturer for additional information.
What's being recalled
Companies: Medtronic Inc., 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432.
How to identify it
Affected products: Restore™ Clinician Programmer Application; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A71100
The hazard
Medtronic is initiating a medical device recall (notification) to notify consignees of a potential for a software issue that may occur when attempting to clear a device reset message using the model A71100 Restore Clinician Programmer application (CP App). The A71100 CP App is used to program the restore family of Spinal Cord Stimulation implantable neurostimulators (INS).
A device reset can occur for a variety of reasons, including when the INS has an overdischarged battery, which is normally cleared during a programming session. In rare cases, the device reset message cannot be cleared and may result in the inability to resume therapy resulting in the patient experiencing a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS to resume therapy.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)