BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIFIX

    MDR report key: 91626 · Received April 13, 1997

    Report

    Report Number
    1640319-1997-00422
    Event Type
    Malfunction
    Date Received
    April 13, 1997
    Manufacturer
    SULZER INTERMEDICS INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON AT LEAST SIX DIFFERENT OCCASIONS, HE HAS SEEN PROBLEMS WITH THE STYLET PACKED WITH THIS LEAD. THE "J" IS SO TIGHT, THAT IT CAUSES THE LEAD TO BE PULLED BACK INTO THE SVC (SUPERIOR VENA CAVA) RATHER THAN ADVANCING INTO THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIFIX Implant PACEMAKER LEAD DTB SULZER INTERMEDICS INC. 438-07 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *