BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIFIX

    MDR report key: 2910836 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15835
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    May 12, 2011
    Report Date
    November 15, 2012
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K922972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18412 CARDIFIX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 438-05

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 4269| (B)(4)| 438-05| 5076| (B)(4)| 1230