BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1945551 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19921
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    June 11, 2010
    Report Date
    October 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE ANALYSIS IS COMPLETE, THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE LEAD WAS RETURNED WITH THE HELIX RETRACTED AND DRIED BLOOD WAS NOTED PAST THE HELIX MECHANISM UP THROUGH THE LEAD LUMEN. ALSO, DEFORMED CONDUCTOR COILS AND CUTS IN THE INSULATION WERE NOTED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. THE HELIX MECHANISM WAS TESTED AND FAILED TO EXTEND. THIS WAS MOST LIKELY DUE TO THE DRIED BODY FLUID IN THE MECHANISM WHICH CONTRIBUTED TO THE FIELD ALLEGATION OF HELIX DIFFICULTIES. ANALYSIS WAS UNABLE TO CONFIRM THE ALLEGATIONS OF DISLODGEMENT AND INCREASED THRESHOLDS. THIS LEAD WAS FOUND TO BE ELECTRICALLY WITHIN SPECIFICATION. THE DAMAGE OBSERVED WAS CONCLUDED AS INDUCED DURING THE EXPLANT PROCEDURE. ALL THERAPY REMAINED AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE RIGHT ATRIAL (RA) LEAD WAS OBSERVED DISLODGED BY X-RAY DURING A SUBSEQUENT EPICARDIAL LEAD IMPLANT PROCEDURE. THE DISLODGEMENT WAS DUE TO TWIDDLERS SYNDROME AND THE LEAD WAS EXTREMELY TWISTED AT THE HEADER. ATRIAL THRESHOLDS HAD INCREASED AS A RESULT. A REPOSITION PROCEDURE WAS ATTEMPTED BUT UNSUCCESSFUL AS THE HELIX FAILED TO DEPLOY. THEREFORE, THIS RA LEAD WAS REPLACED SUCCESSFULLY AND WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention