BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2041822 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01319
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, INVESTIGATION IS CONSIDERED COMPLETE. THIS REPORT 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) DID NOT DELIVER ANTI-TACHYCARDIA PACING WHEN REQUIRED AS A RESULT OF NON-DETECTION. THE HEALTH CARE PERSONNEL RE-PROGRAMMED THIS DEVICE IN ORDER TO MITIGATE THE ISSUE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE PATIENT WAS NOTED TO BE IN VENTRICULAR TACHYCARDIA, A POTENTIALLY LIFE-THREATENING ARRHYTHMIA. IT COULD NOT BE DETERMINED FOR CERTAIN AS TO WHETHER A DETECTION ENHANCEMENT WERE INHIBITING THERAPY.

    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 68 YR 4591| 1860| 0158| N119| 4542