BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOGEN

    MDR report key: 3905749 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11008
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 13, 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) AND RIGHT VENTRICULAR (RV) LEAD, DIFFICULTIES WERE ENCOUNTERED WHEN CONNECTING THE LEAD TO THE DEVICE HEADER. WHEN THE LEAD'S TERMINAL PIN WAS INITIALLY INSERTED INTO THE RV PORT, NOISE WAS NOTED ON THE ELECTROGRAM AND BOTH THE PACING AND SHOCK IMPEDANCE MEASUREMENTS WERE HIGH OUT OF RANGE. THE TERMINAL PIN WAS REMOVED FROM THE HEADER AND REINSERTED; HOWEVER, THE SAME OBSERVATIONS WERE NOTED. AFTER FOUR ATTEMPTS, THE FIELD REPRESENTATIVE PROVIDED MINERAL OIL TO HELP ASSIST WITH THE LEAD INSERTION. AFTER IT WAS USED, THE RV LEAD'S TERMINAL PIN WAS ABLE TO BE FULLY INSERTED INTO THE HEADER AND ALL MEASUREMENTS WERE IN NORMAL RANGE. IN ADDITION, NO FURTHER NOISE WAS OBSERVED ON THE ELECTROGRAMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D AND RV LEAD REMAIN IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384125 AUTOGEN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND G179

    Patients

    Seq Age Sex Outcome Treatment
    1 4672| 0296| G179