BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3213173 · Received July 9, 2013

    Report

    Report Number
    3007566237-2013-02286
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION: PRODUCT ID NEU_UNKNOWN_LEAD: PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE PATIENT WENT THROUGH TRIAL, SHE WAS ¿CRYING IN PAIN¿ WHILE STILL SEDATED. THE PATIENT WAS STILL SEDATED WHILE THE INSTRUCTIONS ON "PROGRAMMER" USE WERE BEING GIVEN, IT WAS RUSHED AND SHE WAS UNABLE TO UNDERSTAND. AFTER ADJUSTMENT, THE STIMULATION WAS TURNED UP HIGH AND WAS HURTING. IT WAS NOTED THAT THE TRIAL WAS 50% OR BETTER AND THE PATIENT WAS RESPONSIVE TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S TRIAL WAS TURNED UP TOO HIGH AND WHEN THEY TURNED THE DEVICE ON FOR THE FIRST TIME THEY GOT A SHOCK IN THE LEG, WHERE THE STIMULATION WAS. IT WAS NOTED THE PATIENT ENDED UP WAITING TWO WEEKS BEFORE TURNING IT ON. IT WAS STATED THE PATIENT WAS HYPERSENSITIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313456 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR