BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3905293 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11168
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 NON-PACER DEPENDENT PATIENT WITH THIS DEVICE SYSTEM WAS PRESENTED WITH A SYNCOPAL EPISODE. UPON FURTHER REVIEW, A MESSAGE DISPLAYING 'CHECK RIGHT VENTRICULAR (RV) LEAD' WAS DISPLAYED. R-WAVE MEASUREMENTS HAD INCREASED FROM 1.7MV TO 4.1MV. ALL OTHER LEAD MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS AND NO NOISE WAS OBSERVED. TECHNICAL SERVICES WAS CONSULTED AND DISCUSSED RECOMMENDATIONS. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME, ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383229 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening 4469| 4470| K063