BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON DR

    MDR report key: 64380 · Received January 16, 1997

    Report

    Report Number
    1640319-1997-00030
    Event Type
    Malfunction
    Date Received
    January 16, 1997
    Date of Event
    December 19, 1996
    Report Date
    January 16, 1997
    Manufacturer
    INTERMEDICS, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER PRESETS FOR SR AND DR MODELS ARE STORED IN THE SAME LOCATION IN THE RX5000 PROGRAMMER. WHEN RECALLED, THE LAST SAVED WILL BE DISPLAYED (UNLESS USER PRESETS HAVE BEEN PREVIOUSLY STORED FOR THE MODEL).

    Description of Event or Problem · 1

    THE RPTR WAS SETTING UP USER PRESET VALUES IN THE RX5000 PROGRAMMER FOR A CO DR AND SR PACEMAKER, WHEN HE FOUND THE FOLLOWING. HE SET UP PUP VALUES FOR SR USING A LIVE DEVICE. HE THEN WENT INTO THE MARATHON DR SCREENS VIA SF1 FROM THE MAINS SCREEN, AND SET UP VALUES FOR THE DR PUP. AGAIN USING A LIVE SR, HE INQUIRED THEM AND RESTORED PUP VALUES. THE SCREEN SHOWED DDDR PUP VALUES, WHICH ARE NOT PROGRAMMABLE IN SR. FURTHER EVENT DISCRIPTION IS ON PAGE 3 OF THIS FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON DR Implant IMPLANTABLE PACEMAKER DXY INTERMEDICS, INC. 294-09 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *