BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOGEN

    MDR report key: 4131446 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14864
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    April 10, 2014
    Report Date
    July 2, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION FROM THE POST MARKET QUALITY ASSURANCE LABORATORY. EVALUATION OF THE RETURNED LV LEAD SHOWED THAT THE MARK LEFT BY THE DEVICE SETSCREW WAS NEAR THE END OF THE TERMINAL PIN, INDICATING THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE HEADER WHEN THE SETSCREW WAS TIGHTENED DOWN. THIS CONNECTION ISSUE LIKELY CONTRIBUTED TO THE IMPEDANCE AND THRESHOLD PROBLEMS OBSERVED CLINICALLY, SECONDARY TO THE REPORTED DISLODGEMENT. THE DEVICE REMAINS IN SERVICE. 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 THE DEVICE FOLLOW-UP, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASED PACING THRESHOLD MEASUREMENTS. LV PACING IMPEDANCE MEASUREMENTS WERE ABOUT 600 OHMS IN THE LV1 UNIPOLAR CONFIGURATION, BUT WERE GREATER THAN 3,000 OHMS IN ALL OTHER CONFIGURATIONS. UNDER FLUOROSCOPY, THE LEAD APPEARED TO BE FULLY INSERTED INTO THE DEVICE HEADER AND THE LEAD WAS CONFIRMED TO BE DISLODGED. A PROCEDURE WAS LATER PERFORMED AND THE LEAD WAS EXPLANTED AND REPLACED, WITH GOOD LEAD MEASUREMENTS REPORTED. THE DEVICE REMAINED IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610456 AUTOGEN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND G179

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4470| 0692| 4674| 4671| G179