BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 7981666 · Received October 18, 2018

    Report

    Report Number
    2124215-2018-18523
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    August 9, 2017
    Report Date
    August 9, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD CONNECTED TO THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS HIGH SHOCK LEAD IMPEDANCE (SLI). THE RV LEAD HAD BEEN AROUND 100-127 OHMS FOR ABOUT A YEAR. TECHNICAL SERVICES DISCUSSED POSSIBLE TROUBLESHOOTING OPTIONS. THE PHYSICIAN WAS GOING TO DECIDE OVER A COMMANDED SHOCK OR LEAD REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821721 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR