BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3142441 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01828
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# VA08CYV, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 355018, LOT# W60056, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING CHEST PAINS IN RECOVERY. HOSPITALIZATION WAS REQUIRED. ABOUT FIVE DAYS LATER, IT WAS REPORTED THE PATIENT WAS HOME. IT WAS UNKNOWN IF THERE WERE ANY INTERVENTIONS TAKEN. ABOUT A WEEK LATER, IT WAS INDICATED THAT THE CAUSE OF THE EVENT WAS UNRELATED TO THE DEVICE. THE PATIENT WAS MONITORED AND RELEASED FROM THE HOSPITAL. IT WAS STATED THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243393 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization