BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN

    MDR report key: 4131721 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14610
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 30, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS PRODUCT WAS INSPECTED AND A HOLE IN THE RIGHT VENTRICULAR (RV) LEAD SEAL PLUG WAS OBSERVED. TESTING VERIFIED NORMAL ELECTRICAL FUNCTION. SETSCREW SEAL PLUGS ARE DESIGNED TO PERMIT SETSCREW WRENCH INSERTION WHILE PREVENTING BODY FLUIDS FROM ENTERING THE HEADER CAVITIES. ON OCCASION, WRENCH PENETRATION CAN DAMAGE A SEAL PLUG WHICH CAN LEAD TO ACCESSORY SENSING PATHWAYS AND POTENTIALLY RESULT IN OVERSENSING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ATTEMPTED, BUT NOT IMPLANTED DUE TO NOISE OBSERVED ON THE RIGHT VENTRICULAR (RV) CHANNEL RESULTING IN OVERSENSING AND PACING INHIBITION FOR A PERIOD GREATER THAN TWO SECONDS. THE PHYSICIAN TRIED DISCONNECTING, THEN RECONNECTING THE LEAD FROM THE HEADER, BUT NOISE WAS STILL OBSERVED. THE PHYSICIAN ELECTED TO REPLACE THE DEVICE WITH A NEW ONE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612647 INOGEN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND G148

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 1888TC| MISMATCH| 5620| 0293| G148