BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1944882 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19456
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 4, 2010
    Report Date
    October 4, 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

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT OVERSENSING WAS OBSERVED ON THE RIGHT ATRIAL (RA) CHANNEL. THE OVERSENSING DID NOT INHIBIT ATRIAL PACING. FIVE ATRIAL TACHYCARDIA RESPONSE (ATR) EPISODES WERE STORED DUE TO NOISE. RA LEAD IMPEDANCE MEASUREMENTS WERE INTIALLY GREATER THAN 2000 OHMS, DECREASING TO 500 OHMS. THE RA PACING THRESHOLD MEASUREMENT INCREASED FROM 1 VOLT TO 3 VOLTS. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4472| 1861| 0157| E110