BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3391592 · Received October 7, 2013

    Report

    Report Number
    2124215-2013-13227
    Event Type
    Injury
    Date Received
    October 7, 2013
    Date of Event
    August 1, 2013
    Report Date
    November 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE DEVICE TO THE POST MARKET QUALITY ASSURANCE LABORATORY OR ADDITIONAL INFORMATION RECEIVED, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS SENT TO BOSTON SCIENTIFIC FOR ANALYSIS. ENGINEERS CONFIRMED THE RETURNED PRODUCT HAD NO TELEMETRY; HOWEVER, ADDITIONAL TESTING WAS NOT PERFORMED DUE TO PENDING LITIGATION.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WITH THIS DEVICE WAS CONTACTED FOR FURTHER TESTING ARRANGEMENTS, HOWEVER REFUSED THIS FURTHER FOLLOW UP AND INDICATED WILL RETURN TO EGYPT WITHIN TWO WEEKS FOR FOLLOW UP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. FURTHER ATTEMPTS TO INTERROGATE THE DEVICE WITH TROUBLESHOOTING TECHNIQUES WERE UNSUCCESSFUL. A DEVICE REPLACEMENT WILL BE PERFORMED WITHIN THE NEXT MONTH.

    Description of Event or Problem · 1

    SUBSEQUENTLY, A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    FURTHER INTERROGATION EFFORTS WERE PERFORMED. AN ELECTROCARDIOGRAM REVEALED THE DEVICE WAS NOT PERFORMING BIV PACING ALTHOUGH IT WAS PROGRAMMED TO BIV PACING AT IMPLANT. TS THOUGHT MAYBE THAT THERE MAY BE EARLY BATTERY DEPLETION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT APPROXIMATELY TWO MONTHS POST IMPLANT, DURING A FOLLOW UP VISIT, THIS DEVICE COULD NOT BE INTERROGATED. IT WAS THOUGHT THIS WAS DUE TO A PROGRAMMER TECHNICAL ISSUE, HOWEVER THE PATIENT WITH THIS DEVICE WAS CONCERNED THEIR DEVICE WAS NOT FUNCTIONING APPROPRIATELY. THE PATIENT WAS DISCHARGED WITHOUT A FOLLOW UP PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AN ADDITIONAL FOLLOW UP WAS PERFORMED. THE PROGRAMMER WAS CHANGED AND TESTING WAS PERFORMED IN A DIFFERENT LOCATION. SIMILAR RESULTS WERE OBTAINED. A CHEST X-RAY WAS PERFORMED VERIFYING THIS DEVICE (COGNIS MODEL P107 SN 123965) IS IMPLANTED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND PROVIDED THE TROUBLESHOOTING TECHNIQUES FOR INTERROGATION. IT WAS THOUGHT THIS WAS DUE TO ENVIRONMENT OR A PROGRAMMER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505583 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R