BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3211562 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08925
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 13, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER PATIENT REACHES THEIR MAXIMUM SENSOR RATE TOO QUICKLY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED REPROGRAMMING THE PARAMETERS AND DECREASING THE RESPONSE FACTOR. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311411 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR K063| 4136| S606| 4135| S602