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Deep Brain Stimulation for Movement Disorders

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • Product Advisories

    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

    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 DBS patients who are implanted with a Medtronic Activa® RC (Model 37612) implantable neurostimulator.

    Read on for detailed information related to this communication.

    Customer Letter


    Product Advisories Archive

    Advisory Archive

    2016

    2015

    DATEADVISORYAFFECTED PRODUCTS
    04/2015 DBS Extension Handling During Implant Procedure Activa® PC (Model 37601), Activa® RC (Model 37612), and the Activa® SC (Model 37603)

    2014

    DATEADVISORYAFFECTED PRODUCTS

    10/2014

    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

    2013

    DATEADVISORYAFFECTED PRODUCTS
    09/2013 Loss of Stimulation and Over Stimulation

    Activa® PC, Activa® RC and Activa® SC deep brain stimulators
    Models 37601, 37602, 37603, 37612

    RestoreUltra® and RestoreSensor® spinal cord stimulators
    Models 37712, 37714

    02/2013 Potential Lead Damage Associated with the DBS Lead Cap DBS Lead Kits:
    Models 3387, 3387S, 3389, 3389S, 3391, 3391S

    Dystonia Kits:
    Models 3317, 3319, 3337, 3339

    2007

    DATEADVISORYAFFECTED PRODUCTS
    10/2007 Recall: Kinetra and Soletra Implanted Neurostimulators

    Kinetra Neurostimulator Model 7428
    Soletra Neurostimulator Model 7426

    2001

    DATEADVISORYAFFECTED PRODUCTS
    05/2001 Diathermy Safety Alert

    Deep Brain Stimulation Neurostimulation Systems

    United States