BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3043185 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03394
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 COMPLAINED OF PALPITATIONS. A DEVICE EVALUATION WAS DONE AND THE PRESENTING ELECTROGRAM (EGM) SHOWED ATRIAL PACING WITH RATE SMOOTHING WHICH WAS CONDUCTING TO THE VENTRICLE, AND THE INTERVALS WERE NEAR THE MAXIMUM PACING RATE OF 120BPM. WHEN THE RATE SMOOTHING FEATURE WAS TURNED OFF THEN THE RATE SLOWED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED POTENTIAL FEATURE INTERACTIONS THAT COULD CAUSE HIGH RATE PACING AND DISCUSSED FURTHER PROGRAMMING OPTIONS. THE DEVICE REMAINS IN SERVICE, AND NO ADDITIONAL ADVERSE PATIENT EFFECTS OR SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146895 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR K063| 4135| 4136