BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 4850301 · Received June 17, 2015

    Report

    Report Number
    3007566237-2015-01679
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 25, 2015
    Report Date
    May 27, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THEIR TRIAL SYSTEM REMOVED AFTER ONLY TWO DAYS BECAUSE THEY THOUGHT THE WIRE HAD MOVED. IT WAS ¿GOOD¿ THE FIRST DAY BUT IT ¿WASN¿T DOING IT ON THE RIGHT SIDE¿ ON THE SECOND DAY. THE PATIENT NOTED THAT SINCE THE FIRST DAY WAS GOOD THAT THEY WANTED TO PROCEED WITH IMPLANT BUT HAD TO SPEAK WITH THEIR HEALTH CARE PROVIDER (HCP). THEY WERE STILL IN PAIN AFTER THE TRIAL BUT IT WAS NOT FROM THE TRIAL, IT WAS FROM BEFORE THE TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394980 EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1