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.
URGENT: MEDICAL DEVICE CORRECTION – SEPTEMBER 2016
DEEP BRAIN STIMULATION THERAPY: IMPORTANT INFORMATION REGARDING THE MODEL 37751 RECHARGER
Models Affected: Model 37751 Recharger, which is included in Model 37651 Charging System for DBS
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 DBS patients who are implanted with a Medtronic Activa® RC (Model 37612) implantable neurostimulator.
Read on for detailed information related to this communication.
Product Advisories Archive
|06/2016||Deep Brain Stimulation Therapy: Important Information Regarding Adaptor Handling During Implant Procedure||
|05/2016||Deep Brain Stimulation Therapy: Reported Events Related to Loss of Coordination||
|05/2016||Deep Brain Stimulation Therapy: Reported Events Related to DBS Tunneling Procedure||
|04/2015||DBS Extension Handling During Implant Procedure||Activa® PC (Model 37601), Activa® RC (Model 37612), and the Activa® SC (Model 37603)|
|Nexdrive Micropositioning Drive||
MI-1000 and MI-2000
|02/2014||Impact of Cycling Feature on Longevity and Recharge Interval||
Activa® PC, Activa® RC, Activa® SC, all Restore® devices (including SureScan®), PrimeAdvanced®, PrimeAdvanced® SureScan® MRI and Itrel® 4 devices
|09/2013||Loss of Stimulation and Over Stimulation||
Activa® PC, Activa® RC and Activa® SC deep brain stimulators
RestoreUltra® and RestoreSensor® spinal cord stimulators
|02/2013||Potential Lead Damage Associated with the DBS Lead Cap||DBS Lead Kits:
Models 3387, 3387S, 3389, 3389S, 3391, 3391S
Models 3317, 3319, 3337, 3339
|10/2007||Recall: Kinetra and Soletra Implanted Neurostimulators||
Kinetra Neurostimulator Model 7428
|05/2001||Diathermy Safety Alert||
Deep Brain Stimulation Neurostimulation Systems