BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVENE

    MDR report key: 6742281 · Received July 25, 2017

    Report

    Report Number
    2124215-2017-13086
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    June 12, 2017
    Report Date
    June 12, 2017
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THIS LEAD AND ASSOCIATED DEVICE DISPLAYED AN INCREASE IN SHOCK IMPEDANCE MEASUREMENTS. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE DEVICE WAS EXPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520383 INTERVENE IMPLANTABLE LEAD DTB GUIDANT ANGLETON/ST. PAUL 497-19

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R