BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3905728 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11267
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 EXPERIENCING INAPPROPRIATE PACING AT THE MAXIMUM SENSING RATE (MSR) WITH THEIR PACEMAKER WHEN MOVING THEIR ARMS. THE RADIO FREQUENCY SETTING IN THE DEVICE WAS FOUND TO BE AT 14 AND WAS LOWERED TO 8, WHILE THE BLENDED SENSOR SETTING WAS PROGRAMMED ON. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) BELIEVED THE INCREASE IN PACING RATE UP TO THE MSR WAS THE RESULT OF MINUTE VENTILATION SENSOR¿S RESPONSE TO UPPER BODY PHYSICAL MOVEMENTS. THE PATIENT WAS DISMISSED AND WILL BE SEEN AT A LATER TIME. THE PACEMAKER CONTINUES TO REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384122 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K187

    Patients

    Seq Age Sex Outcome Treatment
    1 K187