BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3354926 · Received September 18, 2013

    Report

    Report Number
    3004209178-2013-16470
    Event Type
    Malfunction
    Date Received
    September 18, 2013
    Report Date
    August 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V241399, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HAVING FREEZING EPISODES, THEY WERE GETTING WORSE, AND THE PATIENT COULD NOT BE SEEN BY HIS DOCTOR FOR A COUPLE OF DAYS. IT WAS REPORTED THAT THE PATIENT WAS FREEZING UP ALL OF THE TIME AND THE EPISODES LASTED MINUTES, WHICH STARTED ABOUT TWO WEEKS AGO AND THERE HAD BEEN NO FALLS OR TRAUMAS. IT WAS NOTED THAT THE PATIENT SAW HIS DOCTOR LAST WEEK AND THE DOCTOR CHANGED THE SETTINGS TO 0 AND 3, BUT THAT DID NOT WORK. SO, LATER IN THE WEEK, THE PATIENT TALKED TO THE PHYSICIAN¿S ASSISTANT WHO HELPED THE PATIENT ADJUST TO 3 AND 1, WHICH DID WORK UNTIL ABOUT 10PM THAT EVENING AND ALL OF A SUDDEN THE FREEZING STARTED AGAIN. IT WAS VERIFIED THAT STIMULATION WAS ON AT 3 (LEFT) AND 1.5 (RIGHT), AND THE PATIENT MADE SURE THAT THE SINEMET WAS RIGHT WHERE IT SHOULD BE AS WELL. IT WAS INDICATED THAT THE PATIENT WAS DIABETIC AND IT WAS UNCLEAR IF THAT PLAYED A FACTOR. THE PATIENT WAS DIRECTED TO CONTACT HIS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469187 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR