BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1945753 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20266
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATRIAL LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A LEAD SAFETY SWITCH TRIGGERED ON THIS ATRIAL LEAD. THE LEAD WAS PROGRAMMED BACK TO BIPOLAR CONFIGURATION AND IMPEDANCES WERE WITHIN NORMAL RANGE. THE SALES REPRESENTATIVE WAS GOING TO DISCUSS THIS FURTHER WITH THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR (B)(4)| (B)(4)| (B)(4)