BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4132216 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15905
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 18, 2014
    Report Date
    September 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS CONFIRMED TO BE IN SAFETY MODE. 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 MODE. OF NOTE, THIS FAMILY OF DEVICES HAS BEEN SPECIFICALLY DESIGNED SUCH THAT IF THREE SYSTEM RESETS OCCUR WITHIN APPROXIMATELY 48 HOURS, A DEVICE WILL ENTER SAFETY MODE. THE BEHAVIOR OF THIS DEVICE IS CONSISTENT WITH DEVICES THAT HAVE REVERTED TO SAFETY MODE DUE TO ELECTROCAUTERY. DESIGN CHANGES HAVE NOW BEEN IMPLEMENTED TO ENHANCE THE ROBUSTNESS OF ELECTRIC CIRCUITS, SUCH THAT A DEVICE WOULD BE ABLE TO WITHSTAND THE RARE OCCURRENCES OF CONDUCTED ENERGY THAT PREVIOUSLY WOULD HAVE DISRUPTED CIRCUIT PERFORMANCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), IMPLANTED WITH ANOTHER MANUFACTURER'S IMPLANTABLE DEFIBRILLATION LEAD, DELIVERED MULTIPLE INAPPROPRIATE SHOCKS DUE TO OVERSENSED NOISE. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM. DURING THE PROCEDURE, THE PATIENT RECEIVED SOME SHOCKS ALTHOUGH THE DEVICE HAD BEEN PROGRAMMED TO MONITOR ONLY. THE DEVICE WAS INTERROGATED AND FOUND TO BE IN SAFETY MODE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IF ELECTROCAUTERY WAS USED CLOSE TO THE DEVICE IT MAY CAUSE THE DEVICE TO REVERT TO SAFETY MODE. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613094 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 5076| 4543| N140| N119| 0293| 5071| 7304| 6949