BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2040082 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00491
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 4, 2011
    Report Date
    March 23, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. 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. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THE DEVICE TACHY MODE WAS INTENTIALLY TURNED OFF DUE TO NOISE AND THE PATIENT HAS NO HISTORY OF VENTRICULAR TACHYCARDIA EPISODES. THE LEAD AMPLITUDE AND PULSE WIDTH WAS ALSO TURNED DOWN SO THE DEVICE WILL ONLY PACE THE LEFT VENTRICLE. TECHNICAL SERVICES DISCUSSED POTENTIAL ISSUES REGARDING THIS TYPE OF PROGRAMMING AND CONCERN IF OVERSENSING IN THE RIGHT VENTRICLE, WILL INHIBIT BOTH THE RIGHT VENTRICULAR AND LEFT VENTRICULAR PACING. THE CLINICIAN WILL DISCUSS FURTHER WITH THE PHYSICIAN AND CONTINUE TO MONITOR THE PATIENT AND REVISE THE LEAD AT A LATER TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED APPROXIMATELY 7 YEARS LATER THAT THE DEVICE REACHED EXPLANT BATTERY INDICATOR. AT THE REPLACEMENT PROCEDURE, THE PATIENT WAS DOWNGRADED TO A DUAL CHAMBER PACEMAKER. THE RV LEAD WAS SURGICALLY ABANDONED DUE TO HIGH IMPEDANCES AND LOSS OF CAPTURE FROM A CONDUCTOR FRACTURE. THE FRACTURE WAS CONFIRMED BY FLUOROSCOPY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR R/S CHANNEL. SHOCK IMPEDANCE MEASUREMENTS HAD BEEN TRENDING UPWARD. A SHOCK LEAD IMPEDANCE TEST INDICATED OUT OF RANGE IMPEDANCES IN ONE CONFIGURATION. OTHER TESTING CONFIGURATIONS WERE HIGH, BUT NOT OUT OF RANGE. THE DEVICE WAS PROGRAMMED TO A COIL TO CAN CONFIGURATION AND THEN OUT OF RANGE RIGHT VENTRICULAR PACING IMPEDANCES WERE OBSERVED. POCKET MANIPULATION PERFORMED SHOWED A LITTLE NOISE. THE ELECTROGRAM APPEARED "WAVY". WHEN WAVY ELECTROGRAM WAS GONE, IMPEDANCES WERE NORMAL. THE SHOCK VECTOR WAS CHANGED AND THE SENSITIVITY SETTINGS WERE ADJUSTED. THE PATIENT TRAVELS TO WARMER CLIMATES DURING THE WINTER AND WILL BE RE-EVALUATED AGAIN ONCE HE RETURNS FOLLOWING WINTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 80 YR 4136| 0185| 4554| H220| 4555| 4592| 0184| N119