BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2161535 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07670
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 17, 2011
    Report Date
    December 13, 2011
    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

    THE PRODUCTS REMAIN IMPLANTED. 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

    ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCTS 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

    THE DEVICE WAS MODIFIED SURGICALLY AND REMAINS IN SERVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS REMAIN IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION FIVE MONTHS LATER THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD AND DEVICE CONTINUE TO DISPLAY HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. UPON INTERROGATION, THE IMPEDANCE MEASURED 1200-1300 OHMS. ONE EPISODE OF OVERSENSING WAS DETECTED AS VENTRICULAR FIBRILLATION HOWEVER THE RHYTHM LIKELY DID NOT PERSIST AS THE PATIENT DID NOT RECEIVE THERAPY. THE LEAD CONFIGURATION WAS REPROGRAMMED FOR IMPROVED IMPEDANCE MEASUREMENTS. A CHEST X-RAY WAS TAKEN AND NOTHING ABNORMAL WAS NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RECENT SURGICAL INTERVENTION WAS PERFORMED TO EVALUATE THE TRANSVENOUS LEAD. NO MECHANICAL ISSUES WERE NOTED WITH THE LEAD, AND NO LEAD EXTRACTION OR REVISION WAS NEEDED. THE PHYSICIAN RE-CONNECTED AND TIGHTENED THE SET SCREW OF THIS DEVICE WITH THIS LEAD TO HELP REMEDY THE OBSERVED ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    OUR COMPANY RECEIVED ADDITIONAL INFORMATION THAT THE RIGHT VENTRICULAR DEFIBRILLATION LEAD AND DEVICE CONTINUE TO DISPLAY HIGH PACING IMPEDANCE MEASUREMENTS. IT WAS REPORTED THAT A LEAD REVISION PROCEDURE WILL BE PERFORMED IN A FEW WEEKS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD AND DEVICE DISPLAYED HIGH PACING IMPEDANCE VIA THE LATITUDE HOME MONITORING SYSTEM. THE PATIENT WAS SEEN IN THE CLINIC AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PRODUCTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R 4518| N119| 4592| 0185| 4136