BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC- SOLETRA NEUROSTIMULATOR

    MDR report key: 1071092 · Received July 7, 2008

    Report

    Report Number
    MW5007545
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    February 28, 2007
    Report Date
    July 7, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    MHY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF DEEP BRAIN STIMULATOR CAUSED ONGOING, INTERMITTENT ELECTRIC SHOCKS AND LIFE THREATENING EXACERBATION OF DYSTONIA SYMPTOMS. SEVERAL REPEAT PROCEDURES TO REPAIR AND REPLACE LEADS OF DBS WERE SUCCESSFUL; HOWEVER, PT HAS NOT RETURNED TO PRESURGERY BASELINE AND HAS EXPERIENCED SERIOUS INCREASED DISABILITY. THE DANGERS OF MALFUNCTIONING DBS WITH BROKEN OF MIGRATED LEADS CANNOT BE OVERSTATED. DOSE OR AMOUNT: UNK, FREQUENCY: CONTINUOUS, ROUTE: INTRACEREBRAL. DATES OF USE: 2007. DIAGNOSIS OR REASON FO USE: DYSTONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC- SOLETRA NEUROSTIMULATOR DEEP BRAIN STIMULATOR MHY MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening| R| S