BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON DR

    MDR report key: 231580 · Received July 8, 1999

    Report

    Report Number
    1640319-1999-00643
    Event Type
    Malfunction
    Date Received
    July 8, 1999
    Date of Event
    June 7, 1999
    Report Date
    June 10, 1999
    Manufacturer
    INTERMEDICS INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE FOLLOWING OBSERVATIONS WERE SEEN DURING A FOLLOW-UP VISIT: 1) THE PACEMAKER MANUFATURE DATE HAS CHANGED; IT DID READ 1997, AND IT NOW READS 1994. 2) THE INTRINSIC RATE SHOW PACING WITHIN 60-70 PPM, YET THE SENSOR DETERMINED RATES (IN DDD) SHOW 90-110 (50%) AND 140-280 (50%). 3) THE TTA COUNTER SHOWS 65,535 ACTIVATIONS WITHIN ABOUT 10 MINUTES. A PRINTOUT FROM A PREVIOUS FOLLOW-UP VISIT SHOWS 16,777,215 ACTIVATIONS.

    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 72 YR 431-07-89267 (LEAD)| 435-07-00241 (LEAD)