BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 3012371 · Received March 20, 2013

    Report

    Report Number
    3007566237-2013-00833
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    March 3, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT STARTED A TRIAL THREE DAYS BEFORE THE REPORT AND WAS IN THE HOSPITAL FOR DECREASED BLOOD PRESSURE AND DEHYDRATION. THE REPORTER STATED THAT THE EXTERNAL NEUROSTIMULATOR HAD BEEN DROPPED, BUT IT WAS WORKING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116776 EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization