BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3112568 · Received May 14, 2013

    Report

    Report Number
    3007566237-2013-01616
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, SERIAL# UNKNOWN, IMPLANTED: 2010-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD, PRODUCT #3889-28, FOUND THAT ALL OF THE CONDUCTORS WERE BROKEN FIVE CENTIMETERS FROM THE DISTAL END.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT FEEL STIMULATION ANYMORE AND EXPERIENCED LESS THAN 50% THERAPY RELIEF. IMPEDANCES WERE FOUND TO BE ALL OUT OF RANGE; GREATER THAN 4,000 OHMS. THE LEAD WAS CONSEQUENTLY REPLACED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212864 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R