BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN

    MDR report key: 3800002 · Received May 8, 2014

    Report

    Report Number
    2124215-2014-04609
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    February 27, 2014
    Report Date
    April 21, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS DID NOT IDENTIFY ANY DEVICE FUNCTIONAL CHARACTERISTICS THAT WOULD HAVE CAUSED THE OBSERVED HIGH PACING IMPEDANCE MEASUREMENTS.

    Additional Manufacturer Narrative · 1

    FOLLOWING RETURN AND COMPLETION OF LABORATORY ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOLLOWING SUCCESSFUL LEAD PLACEMENT WITH FAVORABLE MEASUREMENTS ON THE PSA, HIGH OUT OF RANGE LEFT VENTRICULAR (LV) AND RIGHT VENTRICULAR (RV) VALUES WERE EXHIBITED, FOLLOWING CONNECTION WITH THIS DEVICE. TROUBLESHOOTING THE CONNECTION OF THE LEAD'S TERMINAL PIN AND HEADER PORT, FAILED TO RESOLVE THE OBSERVED OUT OF RANGE MEASUREMENTS. AS A RESULT, THE DEVICE WAS REMOVED FROM THE IMPLANT PROCEDURE AND ANOTHER BOSTON SCIENTIFIC DEVICE OF SAME MODEL, WAS SUCCESSFULLY IMPLANTED WITH NO LEAD CHANGE IMPLICATIONS. FOLLOWING CONNECTION, ALL SYSTEM MEASUREMENT WERE DEEMED ACCEPTABLE AND THE PROCEDURE COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ATTEMPTED IMPLANT DEVICE IS EXPECTED TO BE RETURNED FOR A POST-MARKET ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279354 INOGEN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND G148

    Patients

    Seq Age Sex Outcome Treatment
    1 G148| 0296| 4678