BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIFIX

    MDR report key: 5624402 · Received May 2, 2016

    Report

    Report Number
    2124215-2016-07239
    Event Type
    Injury
    Date Received
    May 2, 2016
    Date of Event
    January 14, 2016
    Report Date
    January 14, 2016
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    DTB
    PMA / PMN Number
    K955550/S000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 PATIENT WITH THIS PRODUCT DEVELOPED AN INFECTION. A SYSTEM EXTRACTION WAS SCHEDULED. HOWEVER, DUE TO PATIENT'S AGE THE PHYSICIAN BELIEVED THAT THE EXTRACTION PROCEDURE WAS NOT WARRANTED AND MEDICAL MANAGEMENT WAS THE SAFER COURSE OF ACTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279214 CARDIFIX IMPLANTABLE LEAD DTB GUIDANT ANGLETON/ST. PAUL 438-07

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Life Threatening| R 430-07