BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 6026954 · Received October 13, 2016

    Report

    Report Number
    2124215-2016-13869
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    July 13, 2015
    Report Date
    August 4, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    UDI-DI
    00802526516825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    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 FELT THAT THE DEVICE WAS COMING OUT OF THE CHEST. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS SENT BUT NO PERTINENT INFORMATION RECEIVED. THE PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679630 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173 00802526516825

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening 4136| K173| MISMATCH