BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3213098 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10177
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE INITIAL NEEDLE STICK TO IMPLANT THIS RIGHT VENTRICULAR (RV) LEAD, THE PHYSICIAN PERFORATED THE LEFT SUBCLAVIAN VEIN. ATTEMPTS TO REDUCE THE BLEEDING RESULTED IN THROMBOSIS. AT THAT TIME, THE PHYSICIAN ELECTED TO CEASE THE IMPLANT OF THIS SYSTEM AND REMOVE ALL LEADS. THE PATIENT WAS THEN TREATED WITH MEDICATIONS AND REMAINED IN THE HOSPITAL. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314416 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 4479| 4456