BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2281668 · Received October 7, 2011

    Report

    Report Number
    2124215-2011-15255
    Event Type
    Injury
    Date Received
    October 7, 2011
    Date of Event
    March 4, 2011
    Report Date
    August 11, 2011
    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. VISUAL INSPECTION OF THE ATRIAL LEAD REVEALED THE CONDUCTOR COILS WERE CRUSHED AT 215-230 MM FROM THE TERMINAL PIN. IN ADDITION, THE INSULATION ABRASION WAS PRESENT AT 213-225 MM FROM THE TERMINAL PIN. THE ANODE COIL WAS FRACTURED AT 220 MM FROM THE TERMINAL PIN. THE LEAD FAILED ELECTRICAL TESTING DUE TO THE CONDUCTOR FRACTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD EXHIBITED NOISE AND INCREASED THRESHOLDS. A REVISION PROCEDURE WAS PERFORMED; THE LEAD WAS REMOVED AND REPLACED. UPON REMOVAL, THE ATRIAL LEAD APPEARED HEAVILY DAMAGED. THE EXPLANTED LEAD WAS RETURNED FOR ANALYSIS. NO ADDITIONAL 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 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R