BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 2952401 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00118
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN FIRST TURNING ON RAPID ATRIAL PACING (RAP) ON THE EXTERNAL PULSE GENERATOR (EPG), THE VALUE DISPLAYED WAS NOT WHAT WAS EXPECTED. TECHNICAL SERVICES (TS) PROVIDED ASSISTANCE IN RESOLVING THE ISSUE BY TESTING THE RAP AND THE DEFAULT DISPLAYED "EVERY TIME." TS COULD NOT DUPLICATE THE ERROR. THE EPG WAS RESTORED AND REMAINS IN SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55843 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1