BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1970225 · Received January 25, 2011

    Report

    Report Number
    2124215-2011-01265
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    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. INITIAL INSPECTION NOTED THAT THERE WAS BLOOD INFILTRATION IN THE HELIX HOUSING WHICH INHIBITED THE HELIX FROM EXTENDING OR RETRACTING. THERE WAS ALSO CLAVICULAR INSULATION ABRASION APPROXIMATELY 161 TO 168 MM FROM THE TERMINAL PIN. IN ADDITION, THE CONDUCTOR COILS WERE DEFORMED 18 MM FROM THE TERMINAL PIN AND THERE WAS A HOLE FOUND IN THE INSULATION AT THIS SITE, MOST LIKELY DUE TO THE STYLET. THERE WERE ALSO CUTS IN THE INSULATION WHERE THE SUTURE SLEEVE HAD BEEN LOCATED. NEXT, RESISTANCE TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THIS TEST WAS WITHIN NORMAL LIMITS. THE LEAD DID NOT PASS THE PRESSURE TESTING WHICH ASSESSES THE INSULATION INTEGRITY DUE TO THE CUTS AND ABRASIONS IN THE INSULATION. LABORATORY ANALYSIS CONFIRMED THE THAT INSULATION WAS DAMAGED AT THE LOCATION WHERE THE LEAD WOULD HAVE BEEN UNDER THE CLAVICLE WHICH MOST LIKELY CONTRIBUTED TO THE FIELD OBSERVATIONS OF NOISE AND OVERSENSING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH NOISE FROM MYOPOTENTIALS THAT COULD BE RECREATED WITH PATIENT MOVEMENTS. THE NOISE RESULTED IN OVERSENSING BUT NO INAPPROPRIATE SHOCK WAS DELIVERED. IT IS BELIEVE THAT THE INSULATION WAS DAMAGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A LEAD REVISION WAS PERFORMED AND THIS RV LEAD WAS SUCCESSFULLY REPLACED. THE EXPLANTED LEAD WAS THEN 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