BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC PACEMAKERS, INC

    MDR report key: 155571 · Received March 9, 1998

    Report

    Report Number
    155571
    Event Type
    Malfunction
    Date Received
    March 9, 1998
    Date of Event
    February 25, 1998
    Report Date
    March 9, 1998
    Manufacturer
    CARDIAC PACEMAKERS, INC./ELI LILLY AND CO.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER INITIAL IMPLANTATION, DEVICE FAILED TO CAPTURE INTERMITTENTLY. MFR INDICATES THAT IF ANY MOISTURE ENTERS THE HEADER IT WILL FAIL TO PACE. MOISTURE MAY HAVE INADVERTENTLY ENTERED THE HEADER. PT MONITORED. NO FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC PACEMAKERS, INC Implant PACEMAKER DXY CARDIAC PACEMAKERS, INC./ELI LILLY AND CO. 950 *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR