BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 8621235 · Received May 17, 2019

    Report

    Report Number
    3007566237-2019-01091
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    May 17, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE MANUFACTURE REPRESENTATIVE REPORTED THAT THE PATIENT HAD PROBLEMS WITH RECHARGING THEIR INS. THE INS WAS IMPLANTED A WEEK PRIOR AND HAS HAD TROUBLE RECHARGING SINCE THE BEGINNING. THE RECHARGER HAD DIFFICULTIES WITH FINDING THE INS AND THE COUPLING WAS POOR. THE MANUFACTURE REPRESENTATIVE TRIED TO DECOUPLE/COUPLE THE PP WITH THE INS, TOOK OUT THE BATTERIES AND THE ANTENNA THEN AND START ALL OVER AGAIN AND CHECKED THE IMPLANT LOCATION FOR FLUID, THE HOSPITAL STATES THAT THE INS IS IMPLANTED CLOSE TO THE SKIN. IT WAS ALSO NOTED THAT AN ADDITIONAL PROGRAMMER WAS USED BUT THEY WERE STILL UNABLE TO CHARGE IT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414927 NEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1