WIRELESS RECHARGER

Medtronic has identified through a complaint assessment, that the Medtronic WR9200 recharger, contained within the recharger kit RS6200, have had occurrences where the WR device becomes unresponsive. This issue may occur when the WR is fully depleted and the WR is placed on the dock and quickly removed within 20 seconds, interrupting the initialization routine. The recharger patient user guide instructs the user to place the WR on the dock and charge to full before first use. When the wireless recharger becomes unresponsive, the wireless recharger will not respond to a button press, cannot pair with the recharger app, and will cause the recharger battery indicator to continuously flash when placed on the battery dock. In the event of an unresponsive wireless recharger, the user will not be able to charge their implanted Neurostimulator, until a replacement WR device is received. The unresponsive state of the wireless recharger may lead to unanticipated implanted Neurostimulator INS battery depletion. For the Activa INS, if this unanticipated INS battery depletion (over-discharge state) occurs three times, the battery cannot be recharged and will require surgical intervention. This issue can be prevented by adhering to the instructions outlined in the recharger patient user guide.

Recall start date: 2021-11-10