BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC-SOLETRA NEUROSTIMULATOR

    MDR report key: 1071094 · Received July 7, 2008

    Report

    Report Number
    MW5007546
    Event Type
    Injury
    Date Received
    July 7, 2008
    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

    EXACT DATE OF EVENT UNK, BUT OCCURRED SOMETIME DURING 2006-2007 AS REPORTED BY GUARDIAN OF NO. 1. MALFUNCTION OF DEEP BRAIN STIMULATOR CAUSED ONGOING, LIFE THREATENING EXACERBATION OF DYSTONIA SYMPTOMS. EXACERBATION CONTINUES NEARLY UNABATED; THE PT IS LEFT HORRIFICALLY DISABLED, IN CONSTANT DYSTONIC MOVEMENT THAT PROHIBITS USE OF WHEELCHAIR AND ALL OTHER ASSISTIVE DEVICES. AS IS ALSO THE CAUSE WITH PT NO. 1, THE ENTIRE FAMILY IS NOW FINANCIALLY DESTITUTE AND TRAUMATIZED IN EVERY CONCEIVABLE WAY AS A RESULT OF THE DBS RELATED PROBLEMS. THE POTENTIAL DANGERS OF DBS DEVICES AND RELATED SURGERY CANNOT BE OVERSTATED. FREQUENCY AMOUNT: ONGOING, ROUTE: INTRACEREBRAL. DATES OF USE: 2006 OR 2007 TO PRESENT. DIAGNOSIS OR REASON FOR USE: DYSTONIA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    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 20 YR Hospitalization| L| R| S