BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4140222 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17324
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 9, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEAD SAFETY SWITCH (LSS) FEATURE WAS ACTIVATED ON THE RIGHT ATRIAL (RA) LEAD. RA PACING LEAD IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,000 OHMS. THE CONFIGURATION WAS RESET AND THE OUT OF RANGE MEASUREMENT WAS ABLE TO BE REPRODUCED WITH ISOMETRICS. A CLAVICULAR CRUSH WAS SUSPECTED BUT NOT CONFIRMED. A REVISION PROCEDURE WAS PERFORMED AND THE RA LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620596 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R S606| 4469| 4136