BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2163255 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07831
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED MULTIPLE APPROPRIATE SHOCKS THAT FAILED TO CONVERT THE PATIENT'S ARRHYTHMIA. THE PATIENT'S INTRINSIC RHYTHM ENDED THE ARRHYTHMIA. A LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED, WHO CONFIRMED NO DEVICE MALFUNCTION OCCURRED. A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) PROCEDURE WAS PERFORMED. DURING THIS INDUCTION TESTING, THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. AS A RESULT OF THE NIPS PROCEDURE, THERE WAS A SUCCESSFUL SHOCK CONVERSION OF VENTRICULAR FIBRILLATION (VF). ULTIMATELY THE SHOCKING POLARITY WAS REVERSED AT THE DISTAL COIL PORTION OF THE RIGHT VENTRICULAR (RV) LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)