BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIFIX

    MDR report key: 1860445 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-14961
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    June 10, 2010
    Report Date
    July 23, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K922972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL MEASUREMENTS WERE NORMAL AND NO NOISE WAS OBSERVED. THE PHYSICIAN ELECTED TO RE-USE THE LEAD WITH THE NEW DEVICE BASED ON THE PATIENT'S AGE. 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, THIS CHRONIC VENTRICULAR LEAD CAME APART BETWEEN THE ELECTRODE RING AND TERMINAL PIN DURING THE TUG TEST. THEREFORE, THE LEAD WAS REMOVED FROM THE HEADER AND TESTING WAS PERFORMED.

    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 88 YR MISMATCH| 294-03| 430-07| 438-05