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Medtronic is committed to providing you with the highest quality products and services and ongoing support.
As part of our commitment, we have created this forum to house important information learned from ongoing use and experience with our products. We believe the content of these product advisories will further patient safety and improve outcomes.
SPINAL CORD STIMULATION THERAPY: IMPORTANT INFORMATION REGARDING THE MODEL 37751 RECHARGER
Models Affected: Model 37751 Recharger, which is included in Models 37754 and 97754 Charging Systems for SCS
Description:
This notification communicates important information regarding the issue of unresponsive and beeping Model 37751 Rechargers, and provides information on how to prevent occurrence of this issue and restore functionality of the Recharger if the issue occurs. Medtronic has identified an increased number of complaints from customers involving reports of Rechargers that that are in an unresponsive error state, where the Recharger is non-functional with a blank display screen and is beeping every 5 seconds. This Recharger is used by SCS patients who are implanted with the following implantable neurostimulators:
Read on for detailed information related to this communication.
Insufficient Recharging of the Medtronic RestoreSensor™ Implantable Neurostimulators.
Models affected: 37714 and 97714
Description:
This physician communication provides important information regarding reports of rapid battery depletion when a charging session was terminated prior to reaching sufficient battery voltage. When this occurs, the implanted neurostimulator depletes to an overdischarge state in one to two days rather than the typical thirty days. In an overdischarge state, the stimulation therapy is interrupted.
Read on for detailed information related to this communication.