BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKOWN STIMULATOR

    MDR report key: 2964056 · Received February 15, 2013

    Report

    Report Number
    3007566237-2013-00505
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    February 4, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATOR "HAD NOT BEEN FUNCTIONAL FOR PAST TWO YEARS." IT WAS UNCLEAR WHAT NON-FUNCTIONAL MEANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67374 UNKOWN STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1