BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4174629 · Received October 15, 2014

    Report

    Report Number
    2124215-2014-17577
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THIS RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AS CONFIRMED THROUGH CHEST X-RAY. LOSS OF CAPTURE WAS ALSO OBSERVED. A REVISION PROCEDURE WAS PERFORMED WHEREIN THE LEAD WAS SUCCESSFULLY REPOSITIONED. THE LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653983 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R J175| 4456