BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOGEN

    MDR report key: 3904553 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11795
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    February 25, 2014
    Report Date
    April 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 IMPLANT, THE FIELD REPRESENTATIVE REPORTED THAT THE PHYSICIAN HAD TO USE WATER AND MINERAL OIL, TO SUCCESSFULLY INSERT THE LEFT VENTRICULAR LEAD TERMINAL PIN INTO THE DEVICE'S HEADER PORT. THE PIN WAS THEN SUCCESSFULLY SECURED AND THE IMPLANT COMPLETED WITH NO FURTHER REPORTED COMPLICATIONS. TO DATE, THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383013 AUTOGEN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND G177

    Patients

    Seq Age Sex Outcome Treatment
    1 4677| G177| 0185