BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3213540 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10520
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 17, 2013
    Report Date
    October 31, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE CLINIC WAS CONTACTED AND THE CRT-D/PACEMAKER CLINIC NURSE REPORTED THAT THIS PATIENT WAS DECEASED. ACCORDING TO THE NURSE, THAT PATIENT HAD REQUESTED THAT THE DEVICE'S TACHYCARDIA MODE BE PROGRAMMED OFF ON (B)(6) 2013. THIS DATE CORRESPONDS TO THE DATE OF THE ALERT FROM THE PATIENT'S MONITORING SYSTEM. THE NURSE WAS AWARE THAT THE PATIENT HAD DIED BUT THE DATE OF DEATH WAS NOT AVAILABLE. THERE WERE NO ALLEGATION OF DEVICE MALFUNCTION OR THAT THE USE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE EXHIBITED RED ALERT FOR VENTRICULAR TACHYCARDIA MODE SET TO VALUE OTHER THAN MONITOR PLUS THERAPY. ADDITIONAL INFORMATION COULD NOT CONFIRM THE REASON WHY DEVICE WAS REPROGRAMMED TO MONITOR ONLY. THIS CRTD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313091 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening N119| 4087| 0185| 4543