BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2911915 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16396
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 6, 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

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. A CUT IN THE INSULATION WAS NOTED APPROXIMATELY 263 MM FROM THE LEAD'S TERMINAL PIN, AND THERE WAS BLOOD INFILTRATION NOTED INSIDE THE OUTER LUMEN. THE HELIX IS EXTREMELY STRETCHED AND EXTENDS BEYOND THE HELIX HOUSING BY 6 MM. THERE IS ALSO TISSUE ENTWINED IN THE HELIX ALONG WITH ADDITIONAL BLOOD INFILTRATION INSIDE THE HELIX HOUSING. DUE TO THE INFILTRATION AND TISSUE, THE HELIX MECHANISM WAS UNABLE TO EXTEND OR RETRACT THE HELIX. RESISTANCE TESTING WAS PERFORMED TO ASSESS THE LEAD'S ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. TESTING FOR INSULATION INTEGRITY WAS UNABLE TO BE PERFORMED DUE TO THE CUTS FOUND DURING INITIAL INSPECTION. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS OF NOISE, AN INCREASE IN PACING IMPEDANCE MEASUREMENTS, CHANGES IN SENSING MEASUREMENTS AND LOSS OF CAPTURE. DETAILED ANALYSIS FOUND THAT THE LEAD WAS ELECTRICALLY CONTINUOUS. THE DAMAGE TO THE INSULATION AND HELIX WAS MOST LIKELY INDUCED DURING THE EXPLANT OF THE LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD WENT TO THE HOSPITAL COMPLAINING OF VERTIGO WHILE EXERCISING. IT WAS NOTED THAT THERE WAS NOISE ON THE RV LEAD AT THE SAME TIME THAT THE PATIENT WAS EXPERIENCING THE SYMPTOMS. THE NOISE INCREASED WHEN THE PATIENT PRESSED THEIR ARMS TOGETHER. AN INCREASE IN PACING IMPEDANCE MEASUREMENTS, A DECREASE IN SENSING, LOSS OF CAPTURE WAS ALSO NOTED ON THIS LEAD. WHEN THE CONFIGURATION WAS CHANGED FROM BIPOLAR TO UNIPOLAR, BETTER SENSING AND CAPTURE WERE NOTED. THE PACING IMPEDANCE MEASUREMENTS HAD ALSO DECREASED TO 360 OHMS. A CHEST X-RAY WAS PERFORMED AND NO FRACTURE WAS VISIBLE. AN INSULATION ISSUE WAS SUSPECTED. A LEAD REVISION WAS PERFORMED, BUT THERE WAS DIFFICULTY REMOVING THIS LEAD AS THE HELIX WAS UNABLE TO BE RETRACTED. THE LEAD WAS EVENTUALLY ABLE TO BE EXPLANTED, AND THE HELIX WAS DISCOVERED TO BE STRETCHED APPROXIMATELY 3-4 MM OUT OF THE HELIX HOUSING. THE RV LEAD WAS SUCCESSFULLY REPLACED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18265 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R