BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVENE

    MDR report key: 3240022 · Received July 22, 2013

    Report

    Report Number
    2124215-2013-09407
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVY
    PMA / PMN Number
    P940008
    Adverse Event
    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 THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT HAD ENDOCARDITIS. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341102 INTERVENE IMPLANTABLE LEAD NVY GUIDANT ANGLETON/ST. PAUL 497-05

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 497-05| T165| 4054| 101-05| 497-15| 0154| 101-01| 1861