BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2151114 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06564
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED SYNCOPE. THE PATIENT NOTED THIS WAS SIMILAR TO EPISODES THEY HAD PRIOR TO HAVING THE DEVICE. IT WAS RECOMMENDED THAT THE PATIENT CONTACT THEIR PHYSICIAN TO DISCUSS THESE EPISODES. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 86 YR Life Threatening N119| 0185| (B)(4)| MISMATCH| (B)(4)| 4543