BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM DR

    MDR report key: 2812658 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03694
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z261/Z-262-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS ALERTING AND THEY WERE UNABLE TO INTERROGATE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC, INC. 7271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other