BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1946249 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20957
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    March 1, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE AND LEAD REMAIN IN SERVICE. 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

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LATITUDE DETECTED AN ALERT FOR INCREASED SHOCK IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD. THRESHOLD MEASUREMENTS HAD INCREASED AS WELL. SEVERAL NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES WERE PRESENT WITH NOISE ON THE RV LEAD. THE PATIENT IMPLANTED WITH THIS DEVICE SYSTEM WAS REPORTED TO BE VERY SICK ON DIALYSIS AND HAVE SUPERIOR VENA CAVA (SVC) FIBROSIS. TECHNICAL SERVICES PROVIDED RECOMMENDATIONS TO EVALUATE LEAD SYSTEM. COMMANDED ENERGY SHOCKS WERE PERFORMED AND ALL LEAD MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS, HOWEVER, SHOCK LEAD INTEGRITY TESTS EXHIBITED A RV LEAD MEASUREMENT GREATER THAN 125 OHMS. A LEAD REVISION PROCEDURE WAS PLANNED AND THE RV LEAD WAS TO BE REPLACED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT THE PATIENT WAS SEEN FOR A CARDIAC CATHETERIZATION. THE LOCAL FIELD REPRESENTATIVE REVIEWED HISTOGRAMS AND NOTED SOME RATES BELOW THE LOWER RATE LIMIT OF 60 PACES PER MINUTE. IT HAS BEEN SUSPECTED THAT THE LEAD HAS FRACTURED. IT WAS REPORTED THAT THE PATIENT HAD BEEN REALLY SICK AND WAS NOT A GOOD CANDIDATE FOR A LEAD REVISION. ADDITIONAL ELECTROGRAMS WERE SENT IN FOR BOSTON SCIENTIFIC TECHNICAL SERVICES TO REVIEW. AN EPISODE OF PACEMAKER TACHYCARDIA WAS NOTED. RETROGRADE CONDUCTION WAS ELIMINATED AS A SOURCE. THE DEVICE HAS BEEN PROGRAMMED TO MONITOR ONLY. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R 4087| H219| 4047| 0175| 4518| N118