BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE I

    MDR report key: 3922037 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13235
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401070 FINELINE I IMPLANTABLE LEAD DTB GUIDANT ANGLETON/ST. PAUL 4451

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R 6949| T165| 1270| E110| 4451| 4461