BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3210388 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08544
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 ONE DAY POST IMPLANT THIS PATIENT HAD CODED AND A RATE OF 30BPM WAS REPORTED. A BOSTON SCIENTIFIC REPRESENTATIVE REVIEWED THE DEVICE DATA WHICH DID SHOW A PACING PAUSE. THE REPRESENTATIVE PROGRAMMED ON SUDDEN BRADY RESPONSE (SBR). NO ADVERSE PATIENT EFFECTS WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309804 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L K173| 4479| 4456