BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3173717 · Received June 17, 2013

    Report

    Report Number
    3007566237-2013-02003
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    September 14, 2010
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD. (B)(4). REFERENCE MEDWATCH # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DEEP BRAIN STIMULATION ¿DONE¿ IN 2010. IT WAS NOTED THAT AFTER THE LEADS AND BATTERIES WERE PLACE THAT THE PATIENT HAD ¿GREAT AFTER SURGERY RESPONSE AND WAS WITHOUT DYSTONIA AND ABLE TO BE MORE MOBILE.¿ IT WAS FURTHER NOTED THAT ONCE THE VOLTAGE WAS TURNED ON ¿EVERYTHING WENT DOWNHILL.¿ IT WAS NOTED THAT THE PATIENT WAS FALLING, HAD INCREASED TREMORS, AND "CONTINUED TO TAKE MEDICATION WHICH WOULD WORK SOMETIMES BUT NOT LIKE THEY WOULD ON A NORMAL PARKINSON¿S PATIENT.¿ IT WAS NOTED THAT ADJUSTMENTS WERE ATTEMPTED MULTIPLE TIMES. IT WAS NOTED THAT THE PATIENT TURNED THE BATTERIES OFF AT THAT TIME. IT WAS NOTED THAT THE PATIENT "WAS "IN A DEEP DEPRESSION, WAS LOSING POUNDS AND WAS UNABLE TO WORK." IT WAS FURTHER NOTED THAT THE PATIENT'S HEALTH DECLINED SEVERELY. IT WAS NOTED THAT ¿WHATEVER DISEASE HE HAD, IT TOOK HIS LIFE¿ IN 2013. IT WAS NOTED THAT THE PATIENT HAD FALLEN SO MANY TIMES, ¿EVERY TIME THE DOCTOR WOULD TURN UP THE VOLTAGE TO THE POINT WHERE HE WOULD ASK THE DOCTOR IF HE THOUGHT THE WIRES HAD COME LOOSE.¿ IT WAS FURTHER NOTED THAT THE DOCTOR SAID ¿IT HAD NOTHING TO DO WITH THE WIRES, THEY WERE FINE.¿ IT WAS NOTED THAT ¿WE WERE NOT NOTIFIED OF THE RECALL OF THE LEADS THAT WAS ANNOUNCED.¿ IT WAS FURTHER NOTED ¿SINCE THE PATIENT HAD A GOOD AFTER-SURGERY RESPONSE WITH NO LEADS ATTACHED AT THAT POINT, THE DOCTORS GAVE HIM ENCOURAGEMENT IT WOULD HELP. IT WAS NOTED THAT "ONCE THE LEADS AND THE BATTERIES AND THE VOLTAGE WENT ON IT WAS A DISASTER AND DISABLED THE PATIENT.¿ SEE ATTACHED MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273790 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability