BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC PACEMAKERS, INC

    MDR report key: 228005 · Received June 15, 1999

    Report

    Report Number
    228005
    Event Type
    Injury
    Date Received
    June 15, 1999
    Date of Event
    May 11, 1999
    Report Date
    June 14, 1999
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    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

    DESCRIBE EVENT OR PROBLEM: ON ALERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC PACEMAKERS, INC Implant GENERATOR DXY CARDIAC PACEMAKERS, INC. 1176 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R