BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 2951510 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00029
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONLY THE PACING AND SENSING LIGHTS CAME ON WHEN THE EXTERNAL PULSE GENERATOR (EPG) WAS POWERED ON AND THE WORD "SELENA" APPEARED ON THE LOWER DISPLAY. TECHNICAL SUPPORT (TS) HAD THE CALLER MEASURE THE BATTERY VOLTAGE AND IT WAS AT 6.52 VOLTS. THE BATTERY WAS REPLACED AND THE DEVICE WAS OPERATING FINE. THE EPG WAS RESTORED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57163 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1