BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSMOS II

    MDR report key: 87725 · Received April 24, 1997

    Report

    Report Number
    1640319-1997-00358
    Event Type
    Malfunction
    Date Received
    April 24, 1997
    Date of Event
    March 27, 1997
    Report Date
    April 24, 1997
    Manufacturer
    SULZER INTERMEDICS INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBJECTED TO ELECTRICAL/MECHANICAL FUNCTION TESTING AND BATTERY DISCHARGE ANALYSIS. NORMAL PACER OPERATION WAS OBSERVED. THE BATTERY IS PARTIALLY DEPLETED - NORMAL.

    Description of Event or Problem · 1

    THE LAST TELEPHONE CHECK ON JANUARY 25, 1997, SHOWED A BEGINNING OF LIFE (BOL) MAGNET BEHAVIOR. TODAY, THE TELEPHONE CHECK SHOWS THE EARLY REPLACEMENT INDICATOR (ERI), 5 BEATS IN THE SINGLE CHAMBER AT 90PPM FOLLOWED BY THE SINGLE CHAMBER AT 80PPM. THE CALLER WAS CONCERNED THAT INTENSIFIED FOLLOW-UP INDICATOR (IFI) BEHAVIOR WAS NEVER SEEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR