BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1951522 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23285
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 19, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THREE DAYS POST IMPLANT, THIS RIGHT VENTRICULAR LEAD BECAME DISLODGED. A REVISION PROCEDURE WAS PERFORMED; THE LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IN SERVICE. 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 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 4480| S502| 4097