BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3912172 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-12288
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    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 RIGHT VENTRICULAR (RV) LEAD HAS NOT WORKED FROM IMPLANT OR SHORTLY AFTER AND INFORMED THAT DURING THE SURGERY THE LUNG WAS ALSO PUNCTURED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED THE PATIENT TO FOLLOW UP WITH THE PHYSICIAN. ATTEMPTS WERE MADE TO ATTAIN ADDITIONAL INFORMATION WAS UNSUCCESSFUL. ALL AVAILABLE INFORMATION SUGGESTS THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389612 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 4456| S603| 4479