BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3052565 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04543
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 6, 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 THE PATIENT WITH THIS PACEMAKER COMPLAINED OF PALPITATIONS. A DEVICE EVALUATION WAS DONE AND THE PRESENTING ELECTROGRAM (EGM) SHOWED ATRIAL PACING WITH RATE SMOOTHING DOWN THAT WAS CONDUCTING TO THE VENTRICLE, AND THE INTERVALS WERE NEAR THE MAXIMUM PACING RATE OF 120BPM. REPROGRAMMING WAS PERFORMED AND THE RATE DECREASED TO THE LOWER RATE LIMIT OF 60PPM. A MEMORY DOWNLOAD WAS PERFORMED, SENT TO BOSTON SCIENTIFIC FOR EVALUATION, AND AN ENGINEER REVIEWED THE DATA. IT WAS DETERMINED THAT THE HIGH RATE PACING WAS DUE TO A KNOWN INTERACTION BETWEEN SOME FEATURES OF THE DEVICE. ADDITIONAL REPROGRAMMING WAS THEN PERFORMED TO MITIGATE THE ISSUE. 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
    156460 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 4469| 4136| K173