BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5229405 · Received November 17, 2015

    Report

    Report Number
    3004209178-2015-22955
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    October 26, 2015
    Report Date
    October 27, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_RECHARGER_ACC, SERIAL # UNKNOWN, PRODUCT TYPE RECHARGER; PRODUCT ID 3387S-40, LOT # V011938, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V011938, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED DIFFICULTY RECHARGING, POOR COUPLING WHICH HAD STARTED ON (B)(6) 2015. THE PATIENT COULD NOT RECHARGE BATTERY. THEY HAD TRIED MOVING THE DEVICE AROUND AND THE CHARGER PICTURE HAD STAYED EMPTY. THE CHARGER KEPT BEEPING. THE BATTERY WAS TURNED ON/OFF. THE CHARGER HAD FALLEN ON THE FLOOR BUT THERE WAS NO VISIBLE DAMAGE. THE CHARGER SYSTEM HAD SHOWN A PICTURE FROM 3.2 IN THE RECHARGER BOOK, THAT SOMETHING INTERRUPTED THE CHARGER WITH THE DEVICE BATTERY. THE PATIENT HAD TRIED DIFFERENT WAYS TO CHARGE THE BATTERY. THERE WAS A POOR COUPLING SCREEN REPORTED; REPOSITIONING THE ANTENNA AND THE USE OF AN ANTENNA LOCATE FEATURE HAD NOT RESOLVED THE ISSUE. THE PATIENT HAD NOTED THAT IT SEEMED LIKE SOMETHING WAS SHIFTED/SOMETHING LIKE THE WIRES WERE COMING OVER THE TOP OF THE IMPLANTABLE NEUROSTIMULATOR (INS), IT WAS NOT SMOOTH. THE PATIENT HAD SLEPT ON THEIR STOMACH AND FELT THE BATTERY WAS UPSIDE DOWN AND IT WAS NOW CHARGING. THIS WAS NOTICED ON (B)(6) 2015. THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMAS. THE PATIENT HAD CALLED BACK TO CONFIRM THE BATTERY WAS 100% CHARGED. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF MIGRATION ISSUES. THE PATIENT HAD DONE MORE MANIPULATIONS WITH THE BATTERY AND IT HAD STARTED TO CHARGE. NO DIAGNOSTICS WERE DONE, NO ACTIONS WERE TAKEN AND NO HOSPITALIZATIONS WERE RELATED TO THIS EVENT. NO SYMPTOMS WERE REPORTED. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761349 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR