BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3790156 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-09790
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CONFIRMED THAT THE LEAD WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO SYSTEMIC INFECTION. ADDITIONAL INFORMATION INDICATED THAT RA LEAD HAD ELECTRODE END DAMAGE DUE TO AN ADDITIONAL TRACTION UPON LEAD REMOVAL. THE ELECTRODE FRAYED FROM THE MAIN BODY LEAVING THE RING AND ELECTRODE TIPS WITHIN THE SUBCLAVIAN VEIN. IT WAS THEN CONFIRMED THAT ON A LATER DATE, THE LEAD TIP LEFT INSIDE THE PATIENT WAS SUCCESSFULLY REMOVED. THE PRODUCT WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267091 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R 4469| 4456| S203