Official recall record

Medtronic Restore™ Clinician Programmer Application

What the authority reported

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

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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