BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 4140475 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17331
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 24, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SENSORS WERE REPROGRAMMED TO RESOLVE. 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 IMPLANTED WITH THIS PACEMAKER RECENTLY HAD AN AV NODE ABLATION. THE LOWER RATE LIMIT WAS PROGRAMMED TO 90 BEATS PER MINUTE (BPM) POST THE ABLATION. THE LOWER RATE LIMIT WAS LOWERED TO 85 BPM, HOWEVER THE PATIENT'S HEART RATE WAS OBSERVED TO BE ABOVE 90 BPMS. THE HEALTH CARE PROFESSIONAL (HCP) INQUIRED ABOUT THE SENSORS DRIVING THE RATE. TECHNICAL SERVICES DISCUSSED DEVICE PROGRAMMING AND THAT THE MINUTE VENTILATION SENSOR APPEARED TO BE KEEPING THE RATE UP. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618819 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K062

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR MISMATCH| K062