BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 2840698 · Received November 20, 2012

    Report

    Report Number
    3007566237-2012-02791
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, LOT# V009994, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN SAW A FRAYED LEAD INCIDENT SIX MONTHS AGO IN A BATTERY REPLACEMENT. THE LEAD WAS REPLACED, BUT IT WAS UNCLEAR AND THERE WAS NOT SUFFICIENT INFORMATION TO DETERMINE THE DEVICE AND THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1