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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 Safety Notification – May 2016

    Deep Brain Stimulation Therapy: Reported Events Related to Loss of Coordination

    Models Affected: 37612, 37601, 37602, 7428, 7426

    Description:
    This physician notification provides important information on adverse events for DBS Therapy identified through Medtronic’s ongoing surveillance of reported events and published literature. One report has been identified of an inability to swim following DBS implantation and initiation of DBS therapy for Parkinson’s disease in a patient who was an experienced swimmer. Physicians and patients should be aware that loss of coordination is identified in labeling as a potential side effect of DBS therapy, and may result in, for example, the inability to swim. Patients should be made aware that participating in any activities requiring coordination that they were previously able to perform may place them in an unsafe situation; therefore these activities should be performed under supervision after DBS therapy is first turned on and after programming changes until any effects of their DBS therapy on coordination are understood.

    Read on for detailed information related to this communication.

    Customer Letter


    Urgent Medical Device Safety Notification – May 2016

    Deep Brain Stimulation Therapy: Reported Events Related to DBS Tunneling Procedure

    Models Affected: 7483, 37086

    Description:
    This physician notification provides important information on adverse events for DBS Therapy identified through Medtronic’s ongoing surveillance of reported events and published literature. The following serious events or injuries are associated with the DBS implant and tunneling the extension from the lead to the INS:

    • Cases of spinal accessory nerve injury
    • Severe bleeding or vascular injury
    • An extension inadvertently implanted through the ribs and later found to be close to the heart requiring revision
    • Tunneling too superficially resulting in an extension that exited and then re-entered the neck which wasn’t discovered until the surgical drape was removed

    Read on for detailed information related to this communication.

    Customer Letter


    Product Advisories Archive

    Advisory Archive

    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