BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1852123 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-15104
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 9, 2010
    Report Date
    March 8, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION SUGGESTS THAT THIS RA LEAD REMAINS IN SERVICE AT THIS TIME. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    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 THIS CHRONIC TRANSVENOUS RIGHT ATRIAL (RA) LEAD EXHIBITED A PACING IMPEDANCE MEASUREMENT OF 2048 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS OBSERVATION. OF NOTE, THE PATIENT HAS UNDERGONE AN AV NODE ABLATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATES THAT THIS RA LEAD HAS BEEN SURGICALLY ABANDONED. INFORMATION HAS BEEN PROVIDED THAT PATIENT PASSED AWAY FOR AN UNKNOWN REASON. THE SYSTEM IS NO LONGER IN SERVICE.

    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 1746| N118| 4518| H175| 4469| 1600| 0064| 0185