BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3210864 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07265
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 5, 2013
    Report Date
    May 1, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THIS PATIENT WAS RECENTLY CHECKED BY THE HEALTH CARE PROFESSIONAL (HCP) AND IT WAS NOTED THAT THE DEVICE SETTINGS WERE TO AGGRESSIVE CAUSING HIGHER RATES THAN EXPECTED FOR MINIMAL ACTIVITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED CHANGING THE SENSOR SETTINGS TO LESS AGGRESSIVE. ADDITIONALLY ASSES THE PATIENT'S ACTUAL RATE BY SETTING UP SOME TESTING AND HAVE THE PATIENT DO A HALL WALK TO SEE HOW THE DEVICE RESPONDS TO THAT ACTIVITY AND MAKE CHANGES BASED ON THAT INFORMATION. TS ALSO STATED THAT IF THIS PATIENT HAS IRREGULAR BREATHING DUE TO HEART FAILURE THEN THE MINUTE VENTILATION FEATURE MAY NOT BE RESPONDING APPROPRIATELY, SO WATCH THE PATIENT'S BREATHING AS WELL. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311612 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR K063| 4470| 4137