BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE

    MDR report key: 2910853 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15908
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    August 30, 2004
    Report Date
    November 14, 2012
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PHYSICIAN INFORMED THE FIELD REPRESENTATIVE THAT THE RIGHT ATRIAL (RA) LEAD HAD BEEN PREVIOUSLY SURGICALLY ABANDONED DUE TO A LEAD FRACTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18420 THINLINE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 432-04

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Hospitalization| L| R 430-10| 432-04| 1296| 294-09