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Spinal Cord Stimulation

  • 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

    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:

    • Restore® (Model 37711)
    • RestoreUltra® (Model 37712)
    • RestoreAdvanced® (Model 37713)
    • RestoreSensor™ (Model 37714)
    • RestoreUltra® SureScan® MRI (Model 97712)
    • RestoreAdvanved® SureScan® MRI (Model 97713)
    • RestoreSensor® SureScan® MRI (Model 97714)

    Read on for detailed information related to this communication.

    Customer Letter

    Advisory Archive

    2016

    DATEADVISORYAFFECTED PRODUCTS
    05/2016 Insufficient Recharging of the Medtronic RestoreSensor® Implantable Neurostimulators

    Model 37714
    Model 97714

    01/2016

    Upcoming Labeling Updates for Spinal Cord Stimulation

    Specify Model 39565

    Specify Model 39286

    2015

    DATEADVISORYAFFECTED PRODUCTS

    01/2015

    Impact of Cycling Feature on Device Battery Longevity

    InterStim Model 3023

    InterStim II Model 3058

    Itrel 3 Model 7425

    Enterra Model 3116

    2014

    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

    2009

    DATEADVISORYAFFECTED PRODUCTS
    10/2009 Medical Device Correction – Titan Anchor Accessory Kit Titan Anchor Accessory Kit

    United States