BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3830783 · Received May 23, 2014

    Report

    Report Number
    3007566237-2014-01430
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 4, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU _UNKNOWN_LEAD, LOT# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRIAL LEAD WAS FOUND TO BE BROKEN, THE LEAD AND EXTENSION HAD BEEN PULLED OUT OF POSITION, AND THE WIRES WERE FOUND TO BE FRAYED AT A PROCEDURE TO IMPLANT A PERMANENT DEVICE. THE PATIENT NOTED THAT THERAPY STOPPED WORKING THE DAY PRIOR TO THE REPORT. 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
    307336 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR