BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3211342 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08860
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    February 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECEIVED THREE INAPPROPRIATE SHOCKS. THE PATIENT¿S MEDICATION WAS CHANGED. IT WAS ALSO REPORTED THAT AROUND THE SAME TIME THE PATIENT HAD A SYNCOPAL EPISODE IN WHICH THEY FELL AND INJURED THEIR KNEE. IT IS UNCLEAR IF THE SYNCOPAL EPISODE OCCURRED BEFORE OR AFTER THE INAPPROPRIATE SHOCKS AS THE PATIENT IS A POOR HISTORIAN. AS SUCH THE PHYSICIAN IS UNSURE IF OUR DEVICE CAUSED OR CONTRIBUTED TO THE SYNCOPE. SINCE THEN THERE HAVE BEEN NO ADDITIONAL SYNCOPAL EPISODES. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311761 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening 4469| N119| 4548| 0184