BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSMOS II

    MDR report key: 43005 · Received October 11, 1996

    Report

    Report Number
    1640319-1996-00428
    Event Type
    Malfunction
    Date Received
    October 11, 1996
    Date of Event
    September 19, 1996
    Report Date
    October 11, 1996
    Manufacturer
    INTERMEDICS, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT CAME TO DR'S OFFICE. THE PT'S ECG SHOWED SINUS RHYTHM AT 60 TO 70 BPM. AN INQUIRE INDICATED THAT THE DEVICE WAS IN BACKUP. PRESSING THE SFI BUTTON TO INITIATE A BACKUP RESET WAS UNSUCCESSFUL MULTIPLE TIMES. THE DEVICE WILL BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSMOS II Implant IMPLANTABLE PACEMAKER DXY INTERMEDICS, INC. 284-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR