BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 2173632 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11368
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 17, 2011
    Report Date
    August 9, 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 WAS EXPLANTED AND WILL BE RETURNED TO BOSTON SCIENTIFIC. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WILL BE ANALYZED. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. A VISUAL INSPECTION OF THE LEAD REVEALED THE LEAD TIP WAS BENT APPROXIMATELY 25 DEGREES BETWEEN THE HELIX HOUSING AND ELECTRODE RING. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY ANALYSIS CONFIRMED THE LEAD TIP BEING BENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE THIS IMPLANTABLE LEAD WAS FAULTY. ATTEMPTS TO OBTAIN FURTHER INFORMATION ARE CURRENTLY ONGOING. 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