BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1894484 · Received November 9, 2010

    Report

    Report Number
    2124215-2010-21618
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD REPRESENTATIVE REPORTED THAT RE-PROGRAMMING RESOLVED THE OVERSENSING AND THAT ALL OTHER LEAD MEASUREMENTS DIAGNOSTICS REMAINED WITHIN NORMAL LIMITS. 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 INFORMATION THAT OVERSENSING WAS OBSERVED ON THE RATE/SENSE CHANNEL OF THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD, WHICH WAS OCCASIONALLY OVERSENSED CAUSING PACING INHIBITION IN SOME CASES GREATER THAN TWO SECONDS IN DURATION. NO ADVERSE PATIENT EFFECTS WERE OBSERVED. THE CLINICIAN ALSO INQUIRED AS TO WHY LEFT VENTRICULAR PACE MARKERS WEREN'T ALWAYS OBSERVED. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING OPTIONS. SUBSEQUENTLY, IT WAS REPORTED THAT OVERSENSING AND PACING INHIBITION WAS AGAIN NOTED ON THIS LEAD- THIS TIME, INHIBITION DURATION WAS LESS THAN TWO SECONDS AND COULD BE RE-CREATED WITH DEEP BREATHING. NO ADVERSE PATIENT EFFECTS WERE OBSERVED IN EITHER CASE.

    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 76 YR 4542| 0185| 5076| N119