BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIFIX

    MDR report key: 1970211 · Received January 25, 2011

    Report

    Report Number
    2124215-2011-01158
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K960281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION, HOWEVER NO FURTHER INFORMATION WAS AVAILABLE. 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 PLANNED SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIFIX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 435-07

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention (B)(4)| (B)(4)| (B)(4)