BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3904483 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09621
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 13, 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). ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IN SERVICE. 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 LEAD WAS SUCCESSFULLY IMPLANTED. DURING THE IMPLANT, IT WAS OBSERVED THE PATIENT'S ANATOMY WAS TORTUROUS. TWO DAYS LATER, HOLTER MONITORING REVEALED PACING FAILURE. IT WAS THOUGHT THE LEAD HAD BEEN PULLED AND MOVED BACK OUT OF POSITION. A LEAD REVISION WAS PERFORMED. THIS LEAD WAS SUCCESSFULLY REPOSITIONED AT THE CARDIAC APEX. ACCEPTABLE MEASUREMENTS WERE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384004 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4456| J172