BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3212957 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08999
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 7, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 PACING AT THE MAXIMUM SENSING RATE AFTER MINIMAL ACTIVITY. AUTOCAPTURE (AC) IS CURRENTLY PROGRAMMED ON, AND THE PATIENT HAS STABLE THRESHOLDS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED THAT AC SHOULD BE LEFT ON TO PRESERVE BATTERY LIFE AND TO REDO THE TRENDING ON THE MINUTE VENTILATION TO SEE IF THEY CAN ACHIEVE A MORE DESIRABLE RATE RESPONSE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313675 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4068| 1290| 1276| 4243| K173