BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 1863598 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15510
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RA LEAD WAS CAPPED AND REMAINS IN THE PATIENT. A NEW RA LEAD WAS THEN SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING AN UNRELATED REVISION PROCEDURE, IT WAS NOTED THAT THIS RIGHT ATRIAL (RA) LEAD PRESENTED WITH LOW ATRIAL SENSING. A CHEST X-RAY WAS PERFORMED AND REVEALED THAT THIS RA LEAD HAD DISLODGED. 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 Required Intervention