BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3833184 · Received May 27, 2014

    Report

    Report Number
    3007566237-2014-01436
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE EXTENSION, PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE EXTENSION, PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AS OF THE NIGHT PRIOR TO THE REPORT FOR BALANCES ISSUES, FALLING, AND OCCASIONAL SLURRED SPEECH. THE PATIENT STARTED TO HAVE THESE SYMPTOMS AFTER BEING REPROGRAMMED AT THE DOCTOR¿S OFFICE THREE WEEKS PRIOR TO THE REPORT. BOTH SIDES WERE REPROGRAMMED ACCORDING TO THE PATIENT. THE RIGHT SIDE OF THE PATIENT¿S BODY WAS FINE WITH THERAPY, BUT SHE DID NOT FEEL SHE WAS GETTING ANY THERAPY ON THE LEFT SIDE OF HER BODY. THE REPORTER MENTIONED THAT THE PATIENT¿S HUSBAND TRIED TO SHUT STIMULATION OFF THE DAY PRIOR TO THE REPORT. THE STIMULATION STATUS WAS CHECKED USING THE PATIENT PROGRAMMER AND STIMULATION WAS ON FOR BOTH DEVICES. IT WAS NOTED THAT THE PATIENT HAD HAD BENEFIT IN THE PAST ON BOTH SIDES, BUT SHE MENTIONED THAT SHE WOULD GET REPROGRAMMED TO ADDRESS ONE ISSUE AND THEN A DIFFERENT ISSUE WOULD START TO OCCUR. THE PATIENT WANTED TO SEE A NEW NEUROLOGIST AND HAD MADE ARRANGEMENTS TO SEE A NEW DOCTOR FOR POSSIBLE REPROGRAMMING. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311629 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization