BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2050723 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03127
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD TRIPPED THE LEAD SAFETY SWITCH DUE TO UNKNOWN IMPEDANCE MEASUREMENTS. ALL IMPEDANCE MEASUREMENTS WERE NORMAL; HOWEVER, NOISE WAS RECREATED WITH ARM MOVEMENT. NOISE WAS ALSO NOTED ON THE ELECTROGRAMS FOLLOWING THE LEAD SAFETY SWITCH, NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening 4470| 4471| 1194| 1280