BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVENE

    MDR report key: 6288502 · Received January 30, 2017

    Report

    Report Number
    2124215-2016-17766
    Event Type
    Injury
    Date Received
    January 30, 2017
    Date of Event
    October 10, 2016
    Report Date
    October 10, 2016
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68471 INTERVENE IMPLANTABLE LEAD LWS GUIDANT ANGLETON/ST. PAUL 497-24-60

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| L| R 1790| 497-24-60| T135| T175