BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 2161249 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-07950
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 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 TO THE (B)(4) LABORATORY, THE ENTIRE LEAD WAS RETURNED. SEVERAL CUTS WERE NOTED IN THE INSULATION. DRIED BLOOD/BODY FLUID WAS NOTED THROUGHOUT THE HELIX MECHANISM. ANALYSIS CONCLUDED THE LEAD WAS ELECTRICALLY CONTINUOUS. IT WAS THOUGHT THE HELIX MECHANISM ISSUE WAS DUE TO THE DRIED BODY FLUID INFILTRATION INTO THE HELIX MECHANISM AND MAY HAVE CONTRIBUTED TO THE REPOSITIONING DIFFICULTY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT TWO DAYS POST IMPLANT, DURING THE LEFT VENTRICULAR LEAD IMPLANT PROCEDURE, WHEN THE LV LEAD WAS ADVANCED, THIS ATRIAL LEAD DISLODGED. SEVERAL ATTEMPTS TO REPOSITION THIS LEAD WERE UNSUCCESSFUL. THIS LEAD WAS REMOVED, REPLACED AND RETURNED 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 4096

    Patients

    Seq Age Sex Outcome Treatment
    1