BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1771399 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12493
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    May 19, 2010
    Report Date
    June 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THE PHYSICIAN STATED IT WAS USE ERROR THAT THEY DID NOT HAVE ON OF THE TERMINAL PINS CONNECTED CORRECTLY TO THE DEVICE. INFORMATION SUGGESTS THIS DEVICE AND LEAD REMAIN IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED A SHOCK IMPEDANCE OF >125 OHMS ON THIS DEFIBRILLATION LEAD. A CONNECTION ISSUE WAS SUSPECTED. THE LEAD WAS REINSERTED INTO THE HEADER AND THE SHOCK IMPEDANCE WAS THEN 52 OHMS. NO 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 N118

    Patients

    Seq Age Sex Outcome Treatment
    1