BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2913213 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16777
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 10, 2013
    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED THAT THE LEAD'S TERMINAL PIN WAS BENT AND THERE WERE DRAG MARKS NOTED ON THE TERMINAL RING. THE HELIX WAS ALSO BENT AND THERE WAS BLOOD INFILTRATION IN THE HELIX HOUSING. TESTING OF THE HELIX MECHANISM FOUND THAT IT WAS UNABLE TO BE RETRACTED MOST LIKELY DUE TO THE BLOOD INFILTRATION; HOWEVER, THE BEND IN THE HELIX WOULD HAVE HINDERED A FULL RETRACTION INTO THE HELIX HOUSING. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATION OF DISLODGEMENT. HOWEVER, THE BEND IN THE LEAD'S TERMINAL PIN WOULD HAVE PREVENTED INSERTION INTO THE DEVICE HEADER, WHICH WAS OBSERVED DURING THE REVISION. THE BEND IN THE TERMINAL PIN MOST LIKELY OCCURRED DURING THE REVISION PROCEDURE AS A RESULT OF THE FIXATION TOOL BEING REMOVED FROM THE TERMINAL PIN WITHOUT SQUEEZING THE HANDLES TOGETHER.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE WEEK AFTER THE RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS WERE IMPLANTED, A REVISION WAS SCHEDULED AS BOTH LEADS DISLODGED. DURING THE PROCEDURE, THE LV LEAD WAS UNABLE TO BE SUCCESSFULLY REPOSITIONED DUE TO HIGH PACING THRESHOLDS SO THE LEAD WAS EXPLANTED AND REPLACED. THE RA LEAD WAS ALSO UNABLE TO BE REPOSITIONED DUE TO A BLOCKAGE AND THE LEAD WAS EXPLANTED AND REPLACED AS WELL. WHEN THE RA, LV AND THE EXISTING RIGHT VENTRICULAR (RV) LEAD WERE CONNECTED TO THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THERE WAS NO CAPTURE NOTED ON THE RV AND LV LEADS. IN ADDITION, IT WAS REPORTED THAT THERE WAS DIFFICULTY INSERTING THE RV AND LV LEADS INTO THE HEADER DURING THE PROCEDURE. THE CRT-D WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D AND RA LEAD WILL BE RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20687 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R