BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3440005 · Received October 31, 2013

    Report

    Report Number
    3004209178-2013-19940
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Date of Event
    October 9, 2013
    Report Date
    October 10, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389S-40, LOT# VA0224T, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# VA0136M, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WENT TO HER DOCTOR¿S OFFICE ON (B)(6) 2013 AND ¿HE RESET HER THING AND I THINK HE CUT EM TOO HIGH BECAUSE RIGHT AFTER SHE TAKES HER MEDICINE SHE GOES OUT OF CONTROL WITH IT LIKE ITS TOO MUCH MEDICINE¿. THE DOCTOR GAVE HER A PIECE OF PAPER ¿THAT SAID I COULD CONTROL IT BY 4 TENTHS OF A VOLT ON THE ONE SIDE AND DOWN 2 VOLTS ON THE OTHER SIDE OR SOMETHING BUT NOW IT JUST DON¿T WORK AT ALL¿. THE DEVICE WAS SET AT 2.8V ON THE LEFT AND 3.9V ON THE RIGHT. WHEN TRYING TO DECREASE THE RIGHT SIDE , THE LOWER LIMIT REACHED SCREEN DISPLAYED. IF HE TRIES TO INCREASE IT, THE UPPER LIMIT REACH SCREEN DISPLAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560834 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR