BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOGEN

    MDR report key: 3904515 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11759
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    January 14, 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 THE IMPLANT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RESISTANCE WAS ENCOUNTERED WHEN FULLY INSERTING THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS INTO THE HEADER PORTS. THE LEADS WERE ABLE TO BE FULLY INSERTED AND THE CRT-D WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384945 AUTOGEN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND G179

    Patients

    Seq Age Sex Outcome Treatment
    1 5076| 4674| G179| 0295