BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2055501 · Received April 14, 2011

    Report

    Report Number
    2124215-2011-04848
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    March 10, 2011
    Report Date
    January 16, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IT IS SUSPECTED THAT THE DEVICE WAS BURIED WITH THE PATIENT. IF THE DEVICE IS RETURNED THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    APPROXIMATELY SIX YEARS LATER ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE EXPLANTED DUE TO AN UPGRADE. THERE WAS NO INDICATION THAT THE DEVICE HAD BEEN BURIED WITH THE PATIENT AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXHIBITING HIGH OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. A PROCEDURE TOOK PLACE AND THE CONNECTIONS WERE VERIFIED ENSURING THE TERMINAL PIN WAS PAST THE CONNECTOR BLOCK. ONE DAY LATER, THE OUT OF RANGE MEASUREMENTS REAPPEARED. AFTER FURTHER EVALUATION IT WAS COMMUNICATED THIS PATIENT HAD A CORONARY ARTERY BYPASS GRAFT PROCEDURE FIVE DAYS PRIOR TO THE CRT-D IMPLANT. THE PATIENT WAS ALSO VERY SWOLLEN DUE TO AIR IN THEIR CHEST FROM THE CHEST TUBE BEING REMOVED TOO SOON. IT WAS CONCLUDED THAT THE AIR IN THE PATIENT'S CHEST WAS HAVING AN AFFECT ON THE IMPEDANCE MEASUREMENTS. A DISK EVALUATION WAS SENT IN FOR ANALYSIS. FOUR DAILY SHOCK LEAD IMPEDANCE MEASUREMENTS RECORDED WERE 241, 101, 84, AND 60 OHMS. THE MOST RECENT MANUAL SHOCK LEAD IMPEDANCE VALUE WAS 59 OHMS. NO FURTHER ACTION PLANNED TO BE TAKEN AS THE PATIENT'S CONDITION AFFECTING THE SHOCK LEAD IMPEDANCE HAD RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R N119| 4965| 4469| 0180