BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIFIX

    MDR report key: 1944529 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19713
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    September 23, 2010
    Report Date
    October 7, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WAS RETURNED SEVERED 12 CM FROM THE TERMINAL PIN. ONLY THE PROXIMAL PORTION OF THE LEAD WAS RETURNED. SET SCREW MARKS WERE NOTED ON THE TERMINAL PIN AND RING ASSEMBLY. THE OUTER CONDUCTOR COIL WAS MELTED APART AT THE DISTAL END OF MOLDED INSULATION. THIS WAS MOST LIKELY ATTRIBUTED BY ELECTROCAUTERY DAMAGE. THE INSULATION APPEARED BRITTLE AND CRACKED EXPOSING THE CONDUCTOR COILS. RESISTANCE TESTING WAS NOT ACHIEVED SUCCESSFULLY DUE TO THE MELTED CONDUCTOR COIL. LABORATORY ANALYSIS CONFIRMED THE CLINICAL OBSERVATION OF INSULATION DAMAGE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS EXHIBITING OVERSENSING PREVIOUSLY SO THE PHYSICIAN ADJUSTED THE SENSITIVITY ON THE DEVICE. UPON TODAY'S PACEMAKER REPLACEMENT PROCEDURE, THE PHYSICIAN NOTED THAT THE ATRIAL LEAD'S INSULATION WAS COMPLETELY SEVERED. A PORTION OF THE LEAD WAS CAPPED AND ABANDONED IN THE PATIENT AND THE EXPLANTED PORTION WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIFIX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 438-07

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)