BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2053217 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03927
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    January 11, 2011
    Report Date
    March 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, IT IS NOT KNOWN WEATHER THIS LEAD WILL BE RETURNED. UPON ADDITIONAL INFORMATION, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED THRESHOLDS AND PACING IMPEDANCES. A LEAD FRACTURE WAS CONFIRMED AND THIS LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 81 YR Required Intervention 4457| 1292| 4087