BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3904813 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09965
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 14, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT REVIEW OF REMOTE INTERROGATION DATA REVEALED THAT THE DEVICE WAS FUNCTIONING PROPERLY AND THAT ANY EPISODES THE PATIENT HAD WERE NOT FELT TO HAVE CAUSED SYNCOPE. ADDITIONALLY, THE PATIENT EXPERIENCED SHORTNESS OF BREATH (SOB) AND THOUGHT THEY RECEIVED SHOCK THERAPY, HOWEVER, NO SHOCK THERAPY WAS DELIVERED. THE PATIENT REFUSED TO BE SEEN AND THE CAUSE OF SYNCOPE WAS UNDERTEMINED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED A SYNCOPAL EPISODE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383503 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening 4555| T180| 0185| N119| 4087