BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2153613 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06827
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED REPROGRAMMING THE ATRIAL BLANK AFTER VENTRICULAR PACED EVENTS TO MITIGATE THE INAPPROPRIATE ATR EPISODES. ADDITIONALLY, TECHNICAL SERVICES DISCUSSED THE SYNCOPAL EPISODE MAY HAVE BEEN DUE TO THE PATIENT NOT BEING ABLE TO TOLERATE MAXIMUM TRACKING RATE PACING WITHOUT ATRIOVENTRICULAR SYNCHRONY. TECHNICAL SERVICES RECOMMENDED PROGRAMMING THE POST VENTRICULAR ATRIAL REFRACTORY PERIOD ACCORDINGLY. THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE WITHOUT FURTHER COMPLICATION. 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED (B)(4) OVERSENSING ON THE ATRIAL CHANNEL WHICH RESULTED IN INAPPROPRIATE ATRIAL TACHYCARDIA RESPONSE (ATR) EPISODES. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A SYNCOPAL EVENT WHICH CORRESPONDED TO A PACEMAKER MEDIATED TACHYCARDIA (PMT) EVENT.

    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