BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN

    MDR report key: 6518328 · Received April 25, 2017

    Report

    Report Number
    2124215-2017-07074
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    January 12, 2017
    Report Date
    March 21, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    UDI-DI
    00802526533808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DOCUMENTED AND DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER. THE CONSULTANT RECOMMENDED FURTHER TESTING AND OBTAINING AN X-RAY. THE ROOT CAUSE OF THE REPORTED CLINICAL OBSERVATIONS WAS NOT IDENTIFIED AND EFFORTS TO OBTAIN ADDITIONAL PRODUCT ISSUE DETAILS WERE UNSUCCESSFUL. 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 IN A CAR ACCIDENT AND FOLLOWING THE ACCIDENT, PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) CHANNEL ARE VARYING BETWEEN 400-1800 OHMS. POCKET MANIPULATION WAS PERFORMED AND THE MEASUREMENTS REMAINED AT 1800 OHMS. THERE IS NO NOISE OBSERVED AND SENSING, THRESHOLD AND SHOCK IMPEDANCE MEASUREMENTS ARE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300634 INOGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND D011 00802526533808

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR 0184| D011| MISMATCH