BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2173009 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10377
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WILL BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED, OR UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, VISUAL INSPECTION OF THE LEAD CONFIRMED THAT THE DISTAL TIP WAS BENT AT A 19 DEGREE ANGLE BETWEEN THE HELIX HOUSING AND ELECTRODE RING. ADDITIONALLY, DRIED BLOOD WAS NOTED IN THE HELIX MECHANISM UP THROUGH THE LEAD'S LUMEN. THE HELIX WAS NOT ABLE TO BE EXTENDED, DUE TO THE DRIED BLOOD IN THE HELIX MECHANISM. RESISTANCE AND PRESSURE TESTING WAS THEN PERFORMED ON THE LEAD, VERIFYING THE ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW-UP ONE DAY POST-IMPLANT, THIS LEAD WAS FOUND TO HAVE LOSS OF CAPTURE AND UNACCEPTABLE LEAD MEASUREMENTS. A REVISION PROCEDURE WAS DONE AND THIS LEAD WAS EXPLANTED. UPON EXPLANT, VISUAL INSPECTION REVEALED THAT THE LEAD WAS FRACTURED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THIS LEAD WILL BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 Hospitalization| R