BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3360517 · Received September 20, 2013

    Report

    Report Number
    3004209178-2013-16682
    Event Type
    Malfunction
    Date Received
    September 20, 2013
    Report Date
    August 27, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40, LOT# V851361, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40, LOT# V851361, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37651, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    2013 (B)(6). (B)(4) (HCP): IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS NOT LOSING ITS CHARGE QUICKLY AT ALL. IT WAS NOTED THAT AFTER A COUPLE OF DAYS, THE PATIENT WAS ONLY DOWN 20% OF THE CHARGE. IT WAS NOTED THAT ONE OF THE ELECTRODE HAD HIGH IMPEDANCE. IT WAS NOTED THAT BETWEEN CONTACT 1 AND 2 THE IMPEDANCE WAS 5543 OHMS. IT WAS NOTED THAT THE PATIENT WAS PROGRAMMED BETWEEN CONTACTS 0 AND 3 WHERE THE IMPEDANCE WAS 2131. IT WAS NOTED THAT THE PATIENT WAS AT 3.6 VOLTS, 120 PULSE WIDTH, 140 RATE AND 2153 OHMS ON THE LEFT SIDE AND 3.3 VOLTS, 120 PULSE WIDTH, 130 RATE AND 1337 OHMS ON THE RIGHT SIDE. IT WAS NOTED THAT A RECHARGE CALCULATION ESTIMATED THAT IT WOULD TAKE 2.84 WEEKS FOR THE BATTERY TO DEPLETE TO 25% OF THE CHARGE REMAINING. IT WAS NOTED THAT THE PATIENT SAID THAT THE DEVICE WORKED BETTER ABOUT 2 MONTHS AGO. IT WAS NOTED THAT THE PATIENT FELL IN (B)(6) AND A WEEK BEFORE IT STARTED NOT WORKING AS WE LL. IT WAS NOTED THAT THE PROGRAMMING WAS ¿A TAD BIT¿ HIGHER BEFORE. IT WAS NOTED THAT PAST IMPEDANCE MEASUREMENTS WERE UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476947 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR