BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR RESTORE ADVANCED GENERATOR/BATTERY

    MDR report key: 1102283 · Received April 14, 2008

    Report

    Report Number
    1102283
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 12, 2008
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2007, PT UNDERWENT PLACEMENT OF DORSAL COLUMN STIMULATOR IN CERVICAL SPINE. PT RETURNED TO SURGERY IN 2008 FOR REMOVAL AND REPLACEMENT OF DORSAL COLUMN STIMULATOR, DUE TO DIFFICULTIES WITH BATTERY NOT SUPPORTING AND MAINTAINING A CHARGE AND DIFFICULTIES WITH STIMULATION RELATED TO POSITION OF PT'S NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSTIMULATOR RESTORE ADVANCED GENERATOR/BATTERY NEUROSTIMULATOR BATTERY LGW MEDTRONIC VASCULAR * *
    2 LD SURG SPECIFY QUADRIPOLAR 2 MM X 3 MM LEAD GZB MEDTRONIC VASCULAR * V105262

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention