BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3070428 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-06554
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    October 8, 2012
    Report Date
    January 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PHYSICIAN

    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 THAT THE PATIENT WITH THIS PACEMAKER WAS PARTICIPATING IN CARDIAC REHABILITATION. THE HEALTH CARE PROFESSIONAL (HCP) NOTED RATES GOING TO 130 PACES PER MINUTE (PPM) FAIRLY QUICKLY AFTER STARTING EXERCISE AND THEN STAYED AT THAT LEVEL. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS CALLED TO INTERROGATE THE DEVICE WHILE THE PATIENT WAS EXERCISING. A REVIEW OF THE DEVICE MEMORY INDICATED THAT THE PATIENT WAS 100% PACING AT THE PATIENT'S MAXIMUM SENSING RATE OF 130 PPM. THE MINUTE VENTILATION SENSOR WAS REDUCED FROM A SETTING OF 3 TO A SETTING OF 2. THE PATIENT DID NOT REPORT ANY SYMPTOMS. THE PATIENT WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171207 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 4136| K063| 4135