BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC PACEMAKER, INC.

    MDR report key: 59832 · Received November 18, 1996

    Report

    Report Number
    59832
    Event Type
    Malfunction
    Date Received
    November 18, 1996
    Date of Event
    October 24, 1996
    Report Date
    November 18, 1996
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT PERMANENT PACEMAKER PLACEMENT ON 10/24/96. THE PATIENT RETURNED TO THE OPERATING ROOM THE SAME DAY FOR NON-CAPTURE OF THE PACEMAKER. THE SURGEON DETERMINED THERE WAS A MALFUNCTION IN THE VENTRICULAR CHANNEL OF THE HEADER. DUE TO THIS, A NEW PACEMAKER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC PACEMAKER, INC. Implant PACEMAKER GENERATOR DXY CARDIAC PACEMAKERS, INC. CPI MODEL #1230 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR