BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3210187 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06476
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    March 24, 2010
    Report Date
    April 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR HIGH OUT OF RANGE PACING IMPEDANCES ON THE LEFT VENTRICULAR (LV) LEAD. AN IMPEDANCE PLOT WAS REQUESTED BY THE CLINICIAN AND IT WAS NOTED THAT THE IMPEDANCE HAD BEEN INTERMITTENT OUT OF RANGE FOR OVER TWO YEARS. THE PATIENT WAS BROUGHT INTO THE CLINIC AND THEY WERE UNABLE TO REPLICATE THE OUT OF RANGE IMPEDANCE WITH ISOMETRICS. THE PHYSICIAN HAS OPTED TO MONITOR THE PATIENT. REVIEW OF THE DATA BY ENGINEERING REVEALED THAT THE ISSUE IS RELATED TO THE DEVICE AND NOT THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311299 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 4470| N118| 4518| H179| 4086| 0184