BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4220896 · Received November 3, 2014

    Report

    Report Number
    2124215-2014-19385
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE PATIENT IMPLANTED WITH THIS RIGHT ATRIAL (RA) LEAD UNDERWENT OPEN HEART SURGERY. WHEN CANNULATING FOR BYPASS, THE RA LEAD WAS INADVERTENTLY PULLED ENOUGH TO DISLODGE. THE LEAD WAS SURGICALLY ABANDONED AND A NEW RA LEAD IMPLANTED WITHOUT ISSUE. NO ADVERSE ADDITIONAL PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701993 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4469| S606| 4470