Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Percept PC Implantable Neurostimulator (INS) [Model B35200].
The manufacturer has determined that cardioversion may damage the electronics in the Percept PC INS device, making the INS unresponsive and non-functional, meaning that the INS cannot be turned back on. To restore stimulation therapy, surgical replacement of the INS will be required. Cessation of therapy will likely cause a return of disease symptoms. In some cases, symptoms may return with an intensity greater than was experienced prior to implant (rebound effect). In rare cases, this can constitute a medical emergency.
The manufacturer will update the Information for Prescribers manual to add warning language specific to cardioversion and will communicate with users when additional information becomes available. Affected users should follow the action listed on the customer letter issued by the manufacturer.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Oct 2021