BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVENE

    MDR report key: 5623194 · Received May 1, 2016

    Report

    Report Number
    2124215-2016-02598
    Event Type
    Injury
    Date Received
    May 1, 2016
    Date of Event
    January 21, 2016
    Report Date
    January 21, 2016
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    LWS
    PMA / PMN Number
    P940008/S000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 ENDOCARDIAL INFECTION. THE PATIENT WAS STARTED ON INTRAVENOUS ANTIBIOTICS FOR TREATMENT. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCT HAD BEEN ELECTIVELY ABANDONED SURGICALLY PRIOR TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278165 INTERVENE IMPLANTABLE LEAD LWS GUIDANT ANGLETON/ST. PAUL 497-06

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R