BEUDAMED
    FDA Adverse Event Death Summary report: N

    INGENIO

    MDR report key: 3031314 · Received April 2, 2013

    Report

    Report Number
    2124215-2013-05434
    Event Type
    Death
    Date Received
    April 2, 2013
    Date of Event
    January 8, 2013
    Report Date
    March 1, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 FROM THE PATIENT'S SPOUSE THAT THIS PATIENT EXPIRED DUE TO AN INFECTION THREE WEEKS AFTER THE INITIAL IMPLANT PROCEDURE. THE DEVICE WAS A SUSPECTED SOURCE OF THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134113 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death 4136| K063| 4135