BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 4240572 · Received November 10, 2014

    Report

    Report Number
    3007566237-2014-03276
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. PRODUCT ID NEU_INTERSTIM_INS, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT ¿ONE WOULD NOT BELIEVE WHAT SOME OF THE HUSBANDS OF THESE PATIENTS, WHAT THEIR CONVERSATIONS WERE BECAUSE THESE THINGS WERE NOT WORKING.¿ NO SPECIFIC DETAILS WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE INITIAL REPORTER REVEALED THAT HE DID NOT KNOW ANYONE ELSE WHO HAD ISSUES. IT WAS THUS UNCLEAR IF WHAT WAS ORIGINALLY REPORTED WAS TRUE OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723293 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1