BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3912474 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-13346
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PATIENT'S REMOTE MONITORING SYSTEM HAD TRIGGERED AN ALERT INDICATING THAT THE THERAPY DELIVERY OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS DEACTIVATED AND WAS CHANGED TO A MONITOR ONLY MODE FOR AN UNKNOWN REASON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE BUT WERE UNSUCCESSFUL. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391127 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4525| 7274| 6942| 5076| H179| N118| 0085