BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3243670 · Received July 23, 2013

    Report

    Report Number
    2124215-2013-11784
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. SET SCREW MARKS WERE NOTED ON THE TERMINAL PIN AND CUTS WERE NOTED IN THE TIP INSULATION AND DRUG COLLAR. THE HELIX IS EXTENDED AND DRIED BLOOD/BODY FLUID NOTED IN THE HELIX HOUSING AND UP PAST THE NECK REGION. RESISTANCE TEST WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS PASSED. STYLET INSERTION, HELIX MECHANISM AND PRESSURE TESTS WERE NOT PERFORMED. THE LEAD DISLODGEMENT COULD NOT BE CONFIRMED BY ANALYSIS. INDUCED DAMAGE ONLY WAS NOTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS DISLODGED. THIS LEAD WAS EXPLANTED AND REPLACED. THIS LEAD WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343804 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R