BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3213169 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09628
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER EXPERIENCED A SYNCOPAL EPISODE (PASSED OUT). THE PATIENT WAS SEEN IN THE HOSPITAL AND WAS RELEASED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313947 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L 4456| K173| 4135