BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3213072 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10351
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THIS DEVICE OVERSENSED NOISE ON THE COMPETITOR¿S RIGHT VENTRICULAR LEAD THAT LED TO PACING INHIBITION. AS A RESULT, THE PATIENT EXPERIENCED ASYSTOLE FOR APPROXIMATELY 3.4 SECONDS. THE DEVICE WAS PROGRAMMED IN UNIPOLAR MODE WITH AUTOMATIC GAIN CONTROL SENSING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR TECHNICAL ASSISTANCE. A TS CONSULTANT DISCUSSED THAT ACCORDING TO THE DEVICE LABELING, THE DEVICE SHOULD BE PROGRAMMED TO FIXED SENSING WHEN A UNIPOLAR LEAD IS CONNECTED AS THE UNIPOLAR LEAD IS MORE SUSCEPTIBLE TO OVERSENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS PROGRAMMED TO BIPOLAR SENSING AND REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312760 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J175

    Patients

    Seq Age Sex Outcome Treatment
    1