BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY

    MDR report key: 59612 · Received December 18, 1996

    Report

    Report Number
    1640319-1996-00660
    Event Type
    Malfunction
    Date Received
    December 18, 1996
    Date of Event
    November 13, 1996
    Report Date
    December 17, 1996
    Manufacturer
    INTERMEDICS, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RPTR INDICATED THAT THE DIAGNOSIS WAS CORRUPTED. ITP/UBQ PERFFORMED FOR MESSAGE RECEIVED RE: CLOCK=RESET, REVIEWED HISTOGRAM-PROGRAM PROFILE WITH LOSS OF COMMUNICATIONS SECONDARY TO WAND MOVEMENT. INQ=SAW ERI MESSAGE, PROGRAMMED RATE TO 70 PPM TO CLEAR IT. ITP=BINS SHOWED 70-240, 240-180, 260-300. AFTER A BACK-UP RESET WAS DONE, NORMAL BEHAVIOR WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELAY Implant IMPLANTABLE PACEMAKER DXY INTERMEDICS, INC. 294-03 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR