BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN

    MDR report key: 4140455 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17476
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DURING A DEVICE CHECK WHEN THE CLINICIAN WAS PERFORMING THRESHOLD TESTING, THERE WAS A LONG DELAY OF 4 SECONDS UNTIL NORMAL PACING RESUMED ONCE THE END-TEST BUTTON WAS SELECTED. THE PATIENT REPORTED FEELING DIZZY DURING THIS TEST, BUT NO ADVERSE EFFECTS WERE REPORTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND DISCUSSED THAT A DELAY OF 2-3 SECONDS CAN BE EXPECTED, BUT NOTED THIS DELAY SEEMED TOO LONG. TS ALSO DISCUSSED THAT LOSS OF CAPTURE MAY NOT HAVE BEEN RECOGNIZED AT THE APPROPRIATE TIME, CAUSING THE LONGER DELAY (THIS WAS NOTED AS JUST A POSSIBLE EXPLANATION AND NOT THE CONFIRMED CAUSE). THE FIELD REPRESENTATIVE WAS CONTACTED AND WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION AS SHE WAS NOT PRESENT AT THE FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619254 INOGEN IMPLANTABLE CHF GENERATOR NIK GUIDANT PUERTO RICO BV G148

    Patients

    Seq Age Sex Outcome Treatment
    1