BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1870074 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17853
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    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 THIS 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. THIS ISSUE IS DISCUSSED IN OUR Q3 PRODUCT PERFORMANCE REPORT. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WOULD BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WENT INTO SAFETY MODE DURING A REVISION PROCEDURE INVOLVING ELECTROCAUTERY. THE REVISION PROCEDURE WAS TO REMOVE A FRACTURED EXTENDER ASSOCIATED WITH THE TRANSVENOUS RIGHT ATRIAL (RA) LEAD IN THE DEVICE SYSTEM. IN THE ATTEMPT TO REMOVE THE FRACTURED EXTENDER, THE RA LEAD BECAME DISLODGED. BOTH OF THESE PRODUCTS WERE ULTIMATELY REMOVED FROM SERVICE. DURING THE REVISION PROCEDURE, THE DEVICE DID LOSE RADIO FREQUENCY (RF) COMMUNICATION JUST BEFORE ENTERING SAFETY MODE, THEN DELIVERED A SHOCK. THIS CRT-D WAS REMOVED FROM SERVICE AS A RESULT OF ENTERING SAFETY MODE. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS, BEYOND THE SURGICAL INTERVENTION TO ADDRESS THE FRACTURED EXTENDER.

    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 64 YR 6947| 4470| 4542| N119| MISMATCH| 4471| 6987