BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2781029 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12946
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 24, 2012
    Report Date
    November 14, 2012
    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 THE LEAD HAS BEEN RETURNED AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. ONLY THE DISTAL SEGMENT OF THE LEAD WAS RETURNED. THE ELECTRODE END HAD BLOOD FILTRATION IN THE HELIX HOUSING. THE LEAD TIP WAS ALSO FOUND TO BE BENT AT A 6 DEGREE ANGLE BETWEEN THE HELIX HOUSING AND ANODE RING. FURTHER VISUAL INSPECTION NOTED ABRASIONS ON THE LEAD'S INSULATION IN TWO LOCATIONS, INDICATIVE OF LEAD-ON-LEAD CONTACT . AN X-RAY WAS COMPLETED WHICH CONFIRMED THAT THE LEAD'S CONDUCTOR COIL WAS FRACTURED IN ONE OF THE AREAS WHERE THE INSULATION WAS DAMAGED . IT WAS ALSO NOTED THAT THE LEAD SUTURE SLEEVE WAS CLOSE TO THE FRACTURED COIL. LABORATORY ANALYSIS CONFIRMED THE CLINICAL OBSERVATIONS OF NOISE, OVERSENSING, INSULATION DAMAGE AND THE LEAD FRACTURE. BASED ON THE ANALYSIS RESULTS, WE SUSPECT THAT FATIGUE OR STRESS IN THE REGION OF THE FRACTURE SITE DUE TO RELATIVE MOTION BETWEEN THE SUTURE SLEEVE AND AN ANATOMICAL FEATURE LED TO THE FRACTURE. AS A LEAD MOVES IN RESPONSE TO NORMAL HEART RHYTHMS AND BLOOD FLOW, EXTENSIVE FLEXING OVER A PERIOD OF TIME MAY CAUSE FATIGUE OR STRESS, WEAKENING THE COIL, ULTIMATELY RESULTING IN A FRACTURE. THIS CAN OCCUR BETWEEN THE SUTURE SLEEVE AND SOME OTHER PART OF THE ANATOMY. FATIGUE FRACTURES IN THE POCKET OR CLAVICULAR/FIRST RIB AREA ARE WELL KNOWN AND DOCUMENTED IN THE INDUSTRY. A COMBINATION OF LEAD DESIGN, IMPLANT TECHNIQUES, AND PATIENT ANATOMY AND ACTIVITY LEVEL CONTRIBUTE TO THESE TYPES OF OCCURRENCES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE THAT WAS OVERSENSED AND RESULTED IN THE DELIVERY OF INAPPROPRIATE SHOCKS. A LEAD FRACTURE WAS CONFIRMED. DURING THE REVISION PROCEDURE, SEVERAL INSULATION BREACHES WERE NOTED ON THIS LEAD IN THE POCKET REGION. THE PHYSICIAN SUSPECTS THAT LEAD ON LEAD CONTACT CAUSED THE INSULATION ABRASIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED AND WILL BE RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R T175| 4097| 1793| 1741| 0049| 0125