BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2173263 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10688
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED A SYNCOPAL EPISODE. THE FIELD REPRESENTATIVE INDICATED THERE WERE NO EPISODES IN THE ATRIAL LOGBOOK AND THE SYNCOPE WAS BELIEVED TO BE RELATED TO BLOOD PRESSURE, NOT AN ARRHYTHMIA. IN THE COURSE OF CHECKING THE DEVICE, WHILE PERFORMING RIGHT VENTRICULAR (RV) THRESHOLD TESTS, THERE WAS LOSS OF CAPTURE AND THE RADIOFREQUENCY (RF) TELEMETRY WAS LOST, RESULTING IN SEVERAL SECONDS OF NO PACING. IT WAS NOTED THE PATIENT IS PACER DEPENDENT; HOWEVER, THE PATIENT DID NOT PASS OUT WHEN THIS OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR N118| 0184| H175| 4470| 4517