BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3103145 · Received May 9, 2013

    Report

    Report Number
    3007566237-2013-01570
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS AT THE END OF THE SECOND WEEK OF THE TRIAL. THE PATIENT WAS TO GET A STAGE TWO THE DAY OF THE REPORT BUT THE HEALTH CARE PROVIDER (HCP) SUSPECTED AN INFECTION AT THE LEAD INTRODUCER SITE. AFTER PULLING THE LEAD, THE HCP THOUGHT IT DID NOT LOOK INFECTED. THE HCP THOUGHT IT WAS INFECTED BECAUSE THE AREA LOOKED "ANGRY AND A LITTLE RED." THE HCP WANTED TO BE SAFE AND PERFORMED A CULTURE ON THE INTRODUCER AND POCKET SITE. THE EXTENSION SITE "LOOKED FINE." SIX DAYS LATER IT WAS REPORTED THAT THE PATIENT HAD GOOD THERAPY RESULTS BUT DUE TO INFECTION THE IMPLANT HAD TO BE REMOVED. THERE WAS PUS AND ERYTHEMA INDURATION AROUND THE LEAD IMPLANT SITE. A SPINE INFECTION WAS NOT WANTED AND THE INFECTION WAS "VERY DISTURBING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203798 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention