BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1954292 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24560
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN THE LEAD WAS THOROUGHLY ANALYZED. VISUAL INSPECTION CONFIRMED A COMPLETE LEAD WITH A RETRACTED HELIX AND DRIED BLOOD WITHIN THE HELIX MECHANISM. EXTENSIVE TESTING WAS PERFORMED TO ASSESS THE LEAD'S ELECTRICAL AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS DEMONSTRATED CONTINUITY OF THE ELECTRICAL CIRCUITRY AND THE LEAD INSULATION. RIGOROUS TESTING, INCLUDING EXTENSIVE LEAD MANIPULATION WHILE CONNECTED TO AN OHMMETER, VERIFIED THERE WAS NO INTERMITTENCY IN THE ELECTRICAL CONDUCTIVITY. HELIX MECHANISM TESTING WAS UNSUCCESSFUL, MOST LIKELY DUE TO DRIED BLOOD PRESENT WITHIN THE HELIX HOUSING. LABORATORY ANALYSIS OF THE RETURNED PRODUCT WAS UNABLE TO CONFIRM THE REPORTED CLINICAL ALLEGATION.

    Additional Manufacturer Narrative · 1

    FOLLOWING RETURN AND COMPLETION OF LAB ANALYSIS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING IMPLANT, THE PHYSICIAN HAD DIFFICULTY ESTABLISHING FAVORABLE POSITIONING WITH ADEQUATE THRESHOLD MEASUREMENTS. ADDITIONALLY, HELIX MECHANISM DIFFICULTY WAS REPORTED, HOWEVER NOTED THAT THE HELIX HAD NOT BEEN EXERCISED PRIOR TO IMPLANT. AFTER INITIAL IMPLANT SUCCESS, CLINICAL OBSERVATION AND X-RAY IMAGING, CONFIRMED A VESSEL PERFORATION AND ADDITIONAL INTERVENTION NECESSITATED FOR EXCESS BLOOD REMOVAL. AFTER THE PATIENTS CONDITION STABILIZED, THE PHYSICIAN ELECTED TO REPOSITION THE LEAD; HOWEVER, THESE ATTEMPTS WERE WITHOUT AVAIL AND THE PRODUCT ULTIMATELY EXPLANTED. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED WITHOUT FURTHER REPORTED COMPLICATION AND THE EXPLANTED LEAD IS INTENDED TO BE RETURNED FOR POST MARKET EVALUATION.

    Description of Event or Problem · 1

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    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 Required Intervention