BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3040874 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03733
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 6, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS STILL IS USE AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S SYSTEM WAS EXPLANTED DUE TO INFECTION. FOLLOWING THE EXPLANT, THE PATIENT CODED AND THEREFORE, THIS DEVICE AND ASSOCIATED LEAD ARE BEING TEMPORARILY UTILIZED FOR PACING THERAPY UNTIL ANTIBIOTICS ARE ADMINISTERED AND THE INFECTION IS CLEAR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143576 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K062

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R S606| 4136| 4137| 4470| K062