BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIFIX

    MDR report key: 1863798 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-18997
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K922972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS ACTIVELY IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE ELECTIVE PROCEDURE TO REPLACE THIS PATIENT'S PACEMAKER, THE ASSOCIATED LEADS WERE STUCK IN THE DEVICE HEADER. THE LEAD WAS SUCCESSFULLY FREED FROM THE DEVICE. VISUAL INSPECTION OF THE LEAD NOTED SOME SEPARATION BETWEEN THE INTERNAL SEALING RINGS AND THE ANODE RING WHICH WAS SEALED WITH MEDICAL ADHESIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIFIX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 438-05

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 1296| SEDR01| 430-07| 284-05| 438-05