BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2042466 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01572
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS ABANDONED, THEREFORE BOSTON SCIENTIFIC CRM WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS. IT WAS NOTED THAT THE THRESHOLD MEASUREMENTS WERE LIKELY DUE TO EXIT BLOCK. AS A RESULT, THIS LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 4457| 4480| S603| 1298| 4456| 4088