BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROMODULATION STIMULATOR

    MDR report key: 3980437 · Received August 5, 2014

    Report

    Report Number
    3007566237-2014-02183
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CALLER MENTIONED HER AUNT HAVING ANOTHER SYSTEM THAT WOULD TURN ON/OFF WHEN SHE WALKS THROUGH STORE SECURITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456670 UNKNOWN NEUROMODULATION STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR