BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3052680 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03899
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    June 1, 2012
    Report Date
    February 26, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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 THE PATIENT WITH THIS DEVICE SYSTEM WAS REPORTEDLY EXERCISING AND WAS IN SINUS TACHYCARDIA. THE RATE ROSE ABOVE THE MAXIMUM TRACKING RATE (MTR) AND ALL ATRIAL EVENTS WERE IN REFRACTORY, SENDING THE PATIENT INTO VENTRICULAR TACHYCARDIA (VT). THE FIRST SHOCK DELIVERED WAS SUCCESSFUL; HOWEVER, THE PATIENT REMAINED IN SINUS TACHYCARDIA, RETURNING INTO VT. THE DEVICE THEN DELIVERED EIGHT SHOCKS, RESULTING IN THERAPY EXHAUSTION. POST SHOCKS, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM , HOWEVER, NO INJURIES WERE SUSTAINED FROM THE SHOCKS. THE VENTRICULAR RATE RESPONSE (VRR) WAS PROGRAMMED OFF AND THE MTR WAS INCREASED TO ALLOW HIGHER TRACKING PACING. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND SCHEDULED FOR AN EP CONSULTATION. UPON FURTHER REVIEW OF THE ARRHYTHMIA LOGBOOK, A SHOCK HAD BEEN DELIVERED WHERE AN ARRHYTHMIA WAS INDUCED BY A VENTRICULAR PACE SET UP BY CROSS CHAMBER BLANKING AFTER AN ATRIAL PACE. NO FURTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155461 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R 0185| 4470| T135| N118| 4518