BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4140150 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17166
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT HIGH OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENTS. ADDITIONALLY, LOSS OF CAPTURE WAS NOTED AT MAXIMUM OUTPUT. NO LEAD ANOMALIES WERE NOTED ON FLUOROSCOPY DURING A RECENT UPGRADE PROCEDURE. THE LEAD WAS SURGICALLY ABANDONED WHILE THE DEVICE WAS ELECTIVELY EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620938 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4456| 0180| D013| S603| 4469