BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1950317 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22358
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 12, 2010
    Report Date
    December 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE CRT-D WAS PERFORMED. THE DEVICE WAS CONFIRMED TO BE IN SAFETY CORE. REVIEW OF STORED MEMORY VERIFIED THAT THE DEVICE EXPERIENCED THREE SYSTEM RESETS DURING THE TIME OF ELECTROCAUTERY USE, WHICH CAUSED THE DEVICE TO GO INTO SAFETY CORE. OF NOTE, COGNIS DEVICES HAVE BEEN SPECIFICALLY DESIGNED SUCH THAT IF THREE SYSTEM RESETS OCCUR WITHIN APPROXIMATELY 48 HOURS, A DEVICE WILL ENTER SAFETY CORE. THE BEHAVIOR OF THIS CRT-D IS CONSISTENT WITH DEVICES THAT HAVE REVERTED TO SAFETY CORE DUE TO ELECTROCAUTERY.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED TO OFF-ELECTROCAUTERY DURING A VALVE REPLACEMENT PROCEDURE. DURING THE PROCEDURE THE PATIENT'S HEART RATE DECREASED TO 72 PPM. IT WAS DISCOVERED THAT THE DEVICE REVERTED TO SAFETY CORE, HOWEVER IT IS NOT KNOWN EXACTLY WHEN THE DEVICE REVERTED TO SAFETY CORE. THE SURGERY WAS ON THE PATIENT'S RIGHT SIDE AND THE DEVICE WAS IMPLANTED IN THE UPPER LEFT QUADRANT. THERE HAD NOT BEEN ANY UNUSUAL AMOUNT OF ENERGY USED ON THE PATIENT OUTSIDE OF STANDARD ELECTROCAUTERY. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 0125| 4513| H179| 1861| 4136| 0185| 1821| (B)(4)| N118