BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR

    MDR report key: 3132830 · Received May 29, 2013

    Report

    Report Number
    3007566237-2013-01763
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S INS WENT DOWN. A MONTH AGO THE PATIENT WAS QUIETLY WORKING AND SUDDENLY A BIG SHOCK OCCURRED THAT PARALYZED HER. SHE ALSO EXPERIENCED A PAIN IN THE LEFT SIDE THAT WENT UP TO THE ¿NEUROMODULATION¿. SHE REACHED INTO HER PURSE TO GRAB THE PATIENT PROGRAMMER AND WAS ABLE TO PRESS THE STOP BUTTON. THEN A ¿WHITE HOLE¿ AND TOTAL EXHAUSTION. SHE WAITED TO A FEW DAYS TO SEE AN ¿EMERGENCY¿ AND WAS TOLD THAT ¿IT¿S¿ NOTHING AND THAT SHE WAS DEPRESSED. THE INS WAS ¿LIKE A CHARM¿ AND A SMALL ADJUSTMENT WAS NEEDED. SHE FELT NOTHING WEIRD WHEN THE SETTINGS WERE EVALUATED. THE NEXT NIGHT SHE EXPERIENCED SEVERE PAIN IN THE RIGHT ARM, AS IF ¿IT TORE MY ARM¿. SHE WAS TOLD IT WAS NOTHING AND THAT SHE WAS TIRED. TWO DAYS LATER SHE SAW A DOCTOR WHO PRESCRIBED HER MORPHINE AND LATER EXPERIENCED FAINTING, VOMITING, NAUSEA AND HEART ¿MOP¿. IT WAS THOUGHT THAT SHE WAS ALLERGIC TO MORPHINE. THE INS WAS NOT KEEPING UP WITH THE NEW SETTINGS. SHE SUFFERED AN ENTIRE WEEK. IT SEEMED THAT HER TENDONS RECEIVED SUCH A SHOCK AT THE FAILURE THAT IT CAUSED THE PAIN. THE DAY BEFORE YESTERDAY SHE FOUND HERSELF A ¿BLUNDER BY MANIPULATING AN ELECTRIC PLUG WITH WET HANDS¿. ¿THE HOUSING HAS MASS AND WITHOUT ARMS OF MAN NEXT TO HER, SHE WOULD HAVE FALLEN AS PAIN AND ELECTROCUTION WAS STRONG¿. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237370 NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention