BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 2901120 · Received January 8, 2013

    Report

    Report Number
    3007566237-2013-00070
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 13, 2012
    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

    CONCOMITANT MEDICAL DEVICE: PRODUCT ID: 3776, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT SEEMED LIKE A LONGER PORTION OF THE STYLET TIP WAS BENT RESULTING IN MORE DIFFICULTY STEERING AND PATIENTS REPORTING DISCOMFORT DURING IMPLANT. FIVE DAYS LATER, IT WAS REPORTED THAT THIS WAS NOTICED WITH PRE-BENT STYLETS. NO MALFUNCTIONS WERE SEEN, AND THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE REPORTER STATED THE ISSUE OCCURRED DURING A TRIAL. IT WAS NOTED THAT THE LEADS WERE IN PLACE, BUT WITH WHAT APPEARED TO BE A BIGGER BEND THAN NORMAL, THE LEAD POSITION "CHANGED COMPLETELY" AFTER THE STYLET WAS REMOVED AND THE ELECTRODES WERE LEFT IN A SUBOPTIMAL LOCATION. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9496 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1