BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC PACEMAKERS, INC.

    MDR report key: 247631 · Received October 28, 1999

    Report

    Report Number
    247631
    Event Type
    Injury
    Date Received
    October 28, 1999
    Date of Event
    October 25, 1999
    Report Date
    October 27, 1999
    Manufacturer
    CARDIAC PACEMAKERS, INC. ELI LILLY AND CO.
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EARLY FAILURE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC PACEMAKERS, INC. Implant GENERATOR KWY CARDIAC PACEMAKERS, INC. ELI LILLY AND CO. 1276 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R