BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 3923717 · Received July 9, 2014

    Report

    Report Number
    3007566237-2014-01918
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT CAME BACK TO DO THE STAGE 2 PROCEDURE, IT LOOKED INFECTED, AND SO THE LEAD WAS MOVED TO THE OTHER SIDE. THE STAGE 2 WAS COMPLETED ABOUT ¿THREE WEEKS OUT FROM¿ THE STAGE 1 OR ADVANCED EVALUATION. IT WAS NOTED THE PATIENT HAD A HEART CONDITION THAT AROSE BEFORE THE STAGE 2 IMPLANT. THE IMPLANT PROCEDURE WAS POSTPONED UNTIL THE PATIENT RECEIVED CARDIAC CLEARANCE, SO THE PATIENT WAS ON THE STAGE 1 EVALUATION FOR OVER 30 DAYS. REFER TO MANUFACTURER REPORT #3004209178-2014-12764. INFORMATION REASONABLY SUGGESTS THE INFECTION PERSISTED WHEN THE PATIENT HAD THE FULL SYSTEM IMPLANTED. THIS REPORT CAPTURES THE SAME ISSUE WITH THE CURRENTLY IMPLANTED FULL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401431 EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention