BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3050073 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03822
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. 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 IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED TO THE HOSPITAL FOLLOWING A SYNCOPAL EPISODE. REVIEW OF STORED DEVICE MEMORY REVEALED EPISODES OF PACEMAKER MEDIATED TACHYCARDIA (PMT), HOWEVER, IT WAS NOTED THAT THE SYNCOPAL EPISODE OCCURRED PRIOR TO THE PMT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE DEVICE TRACKING PREFERENCE AND BIV TRIGGER FUNCTION. THE CAUSE OF SYNCOPE WAS UNABLE TO BE DETERMINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152179 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening 0185| 4470| 4543| N119