BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3100209 · Received May 8, 2013

    Report

    Report Number
    2124215-2013-07609
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 1, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED DEVICE REPROGRAMMING. RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE WITHOUT FURTHER COMPLICATION. 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 IMPLANTED WITH THIS PACEMAKER EXPERIENCED HEART RATE INCREASES WHEN NOT EXPECTED. DEVICE INTERROGATION REVEALED MINUTE VENTILATION WAS BRINGING THE PATIENT'S RATE UP TO THE MAXIMUM SENSOR RATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201629 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K062

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR K062| 4137