BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3241484 · Received July 22, 2013

    Report

    Report Number
    2124215-2013-11627
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 29, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED TO VENTRICULAR TACHYCARDIA MODE OTHER THAN MONITOR PLUS THERAPY. THE DEVICE DID NOT PROVIDE A TACHY THERAPY. THIS DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341543 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 0180| N119| 5076| E102| T135| 0184| MISMATCH| 4136