BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL NEUROMODUALTION STIMULATOR

    MDR report key: 3920224 · Received July 8, 2014

    Report

    Report Number
    3007566237-2014-01896
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN STAGE TWO THE BATTERY IMPLANT WAS ATTEMPTED ON (B)(6) 2014 BUT UNABLE. IT WAS NOTED THAT THE PATIENT HAD PULLED OUT THIS ELECTRODE ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398060 UNKNOWN EXTERNAL NEUROMODUALTION STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1