BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3324757 · Received September 4, 2013

    Report

    Report Number
    3004209178-2013-15608
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3387S-40, LOT# V032332, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT¿S WIFE THOUGHT THE PATIENT¿S DEVICE WAS IN OVERDISCHARGE. AFTER TROUBLESHOOTING IT WAS DETERMINED THAT THE BATTERY WAS JUST LOW AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ABLE TO GET 6-8 EFFICIENCY BARS. IT WAS NOTED THAT THE PATIENT WOULD TRY AND KEEP THE BATTERY LEVEL AROUND 50% BECAUSE MORE THAN THAT THE PATIENT GETS TOO MUCH STIMULATION AND GETS VERY RIGID, VERY CONFUSED, AND ¿CAN¿T FUNCTION.¿ (NOTE: NO MENTION OF LOSS OF THERAPEUTIC EFFECT FOUND IN THE TRANSCRIPT.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438943 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1