BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3070416 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-06555
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    August 9, 2012
    Report Date
    January 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 HAD BEEN HOSPITALIZED. IT WAS REPORTED THAT THE PATIENT'S HEART RATE WAS AROUND 100 PACES PER MINUTE (PPM). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE HOSPITAL EQUIPMENT WAS LIKELY INTERFERING WITH MINUTE VENTILATION (MV) FEATURE OF THE DEVICE. THE MV WAS TURNED TO PASSIVE WHICH CORRECTED THE UNDESIRED RATE OF PACING. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171315 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR MISMATCH| K063