BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2161286 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-06757
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    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

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT FOLLOWING A CARDIOVERSION, THIS RIGHT ATRIAL LEAD COULD NOT CAPTURE AT MAXIMUM OUTPUT IN BOTH POLARITIES. ADDITIONALLY, THE LEAD SAFETY SWITCH HAD TRIPPED DUE TO IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. THE DEVICE WAS REPROGRAMMED TO VDD MODE DUE TO ATRIAL UNDERSENSING. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    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 76 YR 1296| 4469| 4456