BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1861121 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15477
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 29, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    NOTAPVD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AND AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) PACE/SENSE LEAD HAS CONTRIBUTED TO NOISE AND HIGH, OUT-OF-RANGE PACING IMPEDANCE. OUR TECHNICAL SERVICES TEAM REVIEWED THE EVENT AND BELIEVES THE RA LEAD MAY HAVE A PARTIAL FRACTURE AND RECOMMENDED IT BE REPLACED. ALTHOUGH NO ALLEGATION WAS MADE AGAINST THE LEAD AND NO ADVERSE PATIENT EFFECTS WERE REPORTED, RA LOSS OF CAPTURE WAS REPORTED (DURATION UNKNOWN). (CRITICAL THERAPY REMAINS AVAILABLE VIA THE RV LEAD.)

    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