BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3353556 · Received September 17, 2013

    Report

    Report Number
    3004209178-2013-16427
    Event Type
    Malfunction
    Date Received
    September 17, 2013
    Report Date
    July 22, 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
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40, LOT# V020895, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V020895, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 64002, LOT# N351566, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PATIENT WAS ONLY GETTING 2-4 BARS AND THE BARS WOULD FLUCTUATE. PATIENT WAS CHARGING FOR 4 HOURS A DAY WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) STARTING AT APPROXIMATELY 50% CHARGE. PATIENT WAS NOT SEEING THE ¿BATTERY EXPLODE¿ OR ANY ¿SPRITES¿ WHEN THE INS WAS FULL. IT WAS NOTED THAT THE CORNER FELT MORE PROMINENT THAN THE OTHERS. PATIENT WAS USING A SPORTS BRA TO HELP KEEP ANTENNA IN PLACE. STRESS WOULD TRIGGER PATIENT¿S SEIZURES BUT PATIENT HAD NOT ¿TESTED¿ THE NEW INS FOR STRESS SITUATIONS YET. PATIENT HAD SEIZURES AT NIGHT WHICH THEY WERE TRYING TO CONTROL WITH MEDICATION; PATIENT WAS NOT SURE HOW TO STOP THESE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS LAST SEEN ON (B)(6). THE HEALTHCARE PROFESSIONAL HAD NOTED THAT THE PATIENT HAD NOT HAD ANY SEIZURES SINCE THE DEVICE WAS REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD COME INTO THE OFFICE ON (B)(6) BECAUSE OF RECHARGING ISSUES. IT WAS REPORTED ON (B)(6) 2013 THAT THE PATIENT EXPERIENCED A COUPLING PROBLEM. SHE HAS NEVER BEEN ABLE TO GET THE DEVICE COMPLETELY FULL, GET THE TEAR DROPS (FIRECRACKERS) SCREEN. IT TAKES HER AT LEAST FOUR HOURS TO RECHARGE EVERY TIME AND NOW IT HAS BECOME MORE DIFFICULT TO GET ANY BARS SHADED. THE MOST SHE WAS ABLE TO GET IN THE PAST WAS 4-5 BARS BUT WOULD ONLY LAST A FEW SECONDS. THERE WAS A LITTLE BUMP ON THE RIGHT SIDE OF HER CHEST, IT FELT TILTED LIKE THE RIGHT SIDE WAS STICKING OUT MORE. IT WAS THEN CLARIFIED THAT THE DEVICE FELT LIKE IT HAD AN INDENT, LIKE IT HAD CHANGED, MOVED TO THE RIGHT OR MIGHT HAVE DROPPED. SHE NOTICED THAT ABOUT 3 WEEKS AGO. WHEN USING THE ANTENNA LOCATE FEATURE THE HIGHEST NUMBER SHE COULD GET WAS 52 WITH 2 BARS SHADED. IT WAS NOTED THAT ¿IT WAS STARTING TO HURT AGAIN¿ AND THAT SHE HAS HAD BAD SEIZURES AND HAS FALLEN ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468525 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Female