BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN

    MDR report key: 4140479 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17519
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL PENDING FURTHER EVALUATION FROM THE CLINICAL STUDY ENGINEERS. UPON RECEIPT OF ADDITIONAL INFORMATION, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT PROCEDURE, OUT OF RANGE IMPEDANCE MEASUREMENTS (GREATER THAN 3000 OHMS) AND NO CAPTURE WERE OBSERVED IN CONFIGURATIONS USING THE E2 ELECTRODE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR TROUBLESHOOTING TO NO AVAIL. CONNECTIONS WERE CHECKED DURING IMPLANT AND WERE DEEMED APPROPRIATE. THE PATIENT IS PART OF A CLINICAL STUDY AND THE STUDY ENGINEER RECOMMENDED AN X-RAY TO VERIFY LEAD POSITION AND A POSSIBLE AIR BUBBLE ISSUE OR THAT THE SPRING CONTACT WAS NOT ENGAGING. AS ALL OTHER LEFT VENTRICULAR (LV) CONFIGURATIONS WERE GOOD, THE PHYSICIAN ELECTED TO PROGRAM THE DEVICE TO AN E4 CONFIGURATION AND SENT THE PATIENT HOME. NO FURTHER ISSUES HAVE BEEN REPORTED. THE FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION THAT THE PATIENT'S SPOUSE CALLED TO REPORT THAT THE PATIENT FELT DIZZY WHEN STANDING UP. THE PATIENT WAS NOT CONCERNED OF THESE SYMPTOMS, BUT THE SPOUSE WAS. THE PATIENT HAS NOT SCHEDULED A FOLLOW-UP APPOINTMENT TO THIS DATE, DESPITE THE PHYSICIAN'S RECOMMENDATIONS TO DO SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619324 INOGEN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND G148

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR 4678| 5076| G148| 0692| 4672