BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2914350 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00671
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE RIGHT ATRIAL (RA) LEAD DISPLAYED NOISE, WITH GREATER THAN TWO SECONDS OF PACING INHIBITION. AS A RESULT OF THE OVERSENSING, THE DEVICE DISPLAYED INAPPROPRIATE MODE SWITCHES. ALTHOUGH THE PATIENT'S PHYSICIAN BELIEVED THE RA LEAD TO HAVE FRACTURED, TECHNICAL SERVICES REVIEWED AN ELECTROGRAM (EGM) EPISODE, AND NOTED THAT LIKELY A MUSCLE AND/OR INSULATION ISSUE WAS PRESENT. IT WAS ALSO REPORTED THAT THE PATIENT WITH THIS DEVICE SYSTEM SUFFERED A HISTORY OF TWIDDLIER'S SYNDROME, HOWEVER, IT WAS NOT KNOWN IF THIS HAD CAUSED THE RECENT OBSERVATION. THE PATIENT WAS TO BE BROUGHT IN FOR FURTHER DEVICE REVIEW. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION WENT UNANSWERED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21112 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 4592| 0185| 4136| N119