BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1944949 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19480
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 4, 2010
    Report Date
    October 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD EXPERIENCED LOSS OF CONSCIOUSNESS AND THE PATIENT BELIEVED THAT THE DEVICE'S BATTERY IS AT FAULT. THE PATIENT WAS REFERRED TO THEIR CLINIC TO BE EVALUATED. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THE PATIENT IS THREATENING LEGAL ACTION.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THIS PATIENT IS NON-COMPLAINT AND HAS CALLED THE CLINIC SEVERAL TIMES SAYING THAT HIS DEVICE IS MESSED UP. THE CLINIC SETS APPOINTMENTS FOR THE PATIENT TO BE EVALUATED; HOWEVER, THE PATIENT NEVER SHOWS UP. AT THIS TIME, WE ARE UNABLE TO DETERMINE WHETHER OR NOT THE SYNCOPAL EPISODE IS BEING CAUSED BY THE DEVICE.

    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 66 YR Life Threatening 4525| 0185| N118| 4470