BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC PACEMAKERS, INC.

    MDR report key: 125268 · Received October 6, 1997

    Report

    Report Number
    125268
    Event Type
    Injury
    Date Received
    October 6, 1997
    Date of Event
    September 25, 1997
    Report Date
    October 6, 1997
    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

    DURING INITIAL IMPLANT-FAILURE TO CAPTURE IN THE VENTRICLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R