BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1970250 · Received January 25, 2011

    Report

    Report Number
    2124215-2011-01302
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SUBSEQUENTLY SURGICALLY ABANDONED. AN ACUTE RV LEAD WAS PLACED SUCCESSFULLY. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD HAD MICRODISLODGED. LOSS OF CAPTURE AND HIGH OUTPUT WERE EVIDENT (0.1 VOLTS @ 0.05 MILLISECONDS). THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS, BEYOND THE EARLY SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 1294| S601| 4457| 4456| 4470