BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 3260245 · Received August 1, 2013

    Report

    Report Number
    3007566237-2013-02556
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Report Date
    August 19, 2013
    Manufacturer
    MDT NEUROMODULATION (SULLIVAN LAKE)
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7428, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7428, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    ALL INFORMATION GOING FORWARD WILL APPEAR IN MANUFACTURER REPORT 3004209178-2013-12650 DUE TO ONLY ONE STIMULATOR IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A ¿ZAPPED FEELING IN HER HEAD AND HER HANDS.¿ IT WAS NOTED THAT THE PATIENT IMPEDANCE LEVEL WAS WITHIN RANGE. THE ¿ZAP¿ WAS NOTED AS ¿WHEN YOU CHECK A BATTERY THAT¿S LOW AND YOU PUT IT ON YOUR TONGUE¿. IT WAS REPORTED THAT THE PATIENT¿S TREMORS ARE WELL SUPPRESSED. IT WAS ALSO NOTED THAT THERE WERE NO REPORTED FALLS OR TRAUMAS AND THE ¿¿ZAPPING¿ BEGUN ABOUT TWO WEEKS BEFORE REPORTED EVENT DATE. THE LAST PROGRAM AND STIMULATION CHANGE WAS IN OCTOBER 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360727 UNKNOWN DEEP BRAIN STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT NEUROMODULATION (SULLIVAN LAKE) NEU_INS_STIMULATOR UNKNLOWN

    Patients

    Seq Age Sex Outcome Treatment
    1