BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1950907 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22798
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 12, 2010
    Report Date
    November 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INFORMATION KNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, IT WAS NOTED THERE WAS LOSS OF CAPTURE. IMPEDANCE MEASUREMENTS OF THIS RIGHT VENTRICULAR LEAD WERE WITHIN NORMAL LIMITS. A REVISION PROCEDURE WAS PERFORMED, THE LEAD WAS REPOSITIONED SUCCESSFULLY. POST REVISION PROCEDURE, IT WAS NOTED A SMALL PERICARDIAL EFFUSION THAT REQUIRED NO INTERVENTION. 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 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention