BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE

    MDR report key: 2942490 · Received February 4, 2013

    Report

    Report Number
    2124215-2013-01080
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 11, 2012
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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
    46131 THINLINE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 430-10

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R 430-10| 294-05| 432-04| MISMATCH