BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3946919 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-13279
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED AN ELECTRIC SHOCK OF 220 VOLTS WHILE USING AN AUTOGENOUS WELDER. THE PATIENT EXPERIENCED WORSENING STIFFNESS, ¿A PREDOMINANCE OF RIGHT SIDE¿, WITH INCREASED LINGUIAL DYSKINESIAS AND RESIDUAL TREMOR. THE PATIENT¿S SYMPTOMS HAD INCREASED IN THE THREE DAYS PRIOR TO THE PATIENT¿S VISIT WITH THE PHYSICIAN. WHILE THE HCP WAS ATTEMPTING TO ADJUST THE IMPLANTABLE NEUROSTIMULATOR (INS), THE DEVICE SUDDENLY TURNED OFF, WITH PARAMETERS SET TO 0 VOLTS, 0 MICROSECONDS, AND 0 HERTZ. THE DEVICE HAD TO BE RESTARTED. PRIOR TO THE PATIENT BEING SHOCKED, THE DEVICE PARAMETERS AND IMPEDANCES WERE AS FOLLOWS: LEFT INS: C+, 0-, 1-, 2.8 V, 90 MICROS, 130 HZ RIGHT INS: C+, 10-, 3.0 V, 90MICROS, 130 HZ IMPEDANCES IN OHMS, MEASURED AT 0.7 V: C/3 3183, C/3 4165, 1/3 4107, 2/3 4586, C/8 2128, C/9 4805, C/11 2406, 8/9 5794, 8/11 4201, 9/10 4886, 9/11 6729 AFTER EXPERIENCING THE SHOCK, THE DEVICE PARAMETERS WERE AS FOLLOWS: LEFT INS: C+, 1-, 2-, 3.5 V, 90 MIROS, 130 HZ RIGHT INS: C+, 9-, 10-, 3.5 V, 90 MICROS, 130 HZ IMPEDANCES WERE OUT OF RANGE ON ELECTRODE PAIRS C/2 AND C/3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424632 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1