BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2910001 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15090
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 31, 2012
    Report Date
    May 17, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE REMAINS IN SERVICE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED AND MEMORY DUMP WAS SENT INTO A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT FOR REVIEW. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT REVIEWED THE MEMORY DUMP AND DISCUSSED THAT ALL THE ELECTRICAL PARAMETERS LOOK NORMAL BASED ON THE HIGH OUT PUTS FROM THE DEVICE. THE AVERAGE POWER IS STILL ADJUSTING FROM THE PREVIOUS HIGH OUTPUT SETTINGS. IN CONCLUSION, BASED ON THE DATA FROM THE DEVICE AND HOW IT WAS PROGRAMMED OVERTIME THE LONGEVITY AND GAS GAUGE POSITIONS APPEAR TO BE APPROPRIATE. PLEASE NOTE THE PATIENT IS IN MOST LIKELY IN ATR 100% OF THE TIME AND PROGRAMMING CHANGES WERE RECOMMENDED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE REMAINS IN SERVICE AT THIS TIME. A MEMORY DUMP WAS REQUESTED BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT FOR REVIEW. ADDITIONAL INFORMATION WAS RECEIVED FROM THE AFFILIATE THAT A MEMORY DUMP MAY NOT BE PERFORMED UNTIL THE NEXT FOLLOW; THEREFOR AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. IF THE PRODUCT IS RETURNED TO BOSTON SCIENTIFIC LABORATORY ANALYSIS WILL BE PERFORMED TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT. THIS INVESTIGATION WILL BE UPDATED AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE REMAINS IN SERVICE AT THIS TIME. A MEMORY DUMP WAS SENT INTO A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT FOR REVIEW. A FINAL REPORT WILL BE SENT AFTER INFORM IS RECEIVED OF THE MEMORY DUMP. IF THE PRODUCT IS RETURNED TO BOSTON SCIENTIFIC LABORATORY ANALYSIS WILL BE PERFORMED TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    ---

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A REVISION PROCEDURE TOOK PLACE TO IMPLANT A NEW RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH THRESHOLDS. THE CONNECTION WAS CHECKED AND THE LEAD WAS TESTED AND ALL MEASUREMENTS WERE CONFIRMED STABLE. IT WAS NOTED THAT BEFORE THE LEAD REVISION, THE EXPECTED BATTERY LIFESPAN OF THE DEVICE WAS 1 YEAR. AFTER THE REVISION THE BATTERY LIFE HAD CHANGED AFTER REPROGRAMMING AND THE NEW EXPECTED LIFESPAN WAS APPROXIMATELY 8 YEARS. TWO DAYS POST THE REVISION, AT A FOLLOW UP VISIT, THE EXPECTED LIFESPAN OF THE DEVICE CHANGED AGAIN TO 1.5 YEARS REMAINING. THE ESTIMATED BATTERY LONGEVITY ON THE DEVICE WAS NOT AS EXPECTED. PREMATURE BATTERY DEPLETION (PBD) WAS SUSPECTED BY THE PHYSICIAN DUE TO THE BATTERY INDICATOR DISCREPANCY. A MEMORY DUMP OF THE DEVICE WAS SENT INTO A TECHNICAL SERVICE AGENT FOR REVIEW. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18491 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R