BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 7190703 · Received January 15, 2018

    Report

    Report Number
    2124215-2017-19500
    Event Type
    Injury
    Date Received
    January 15, 2018
    Date of Event
    October 16, 2017
    Report Date
    October 17, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A HEART RATE IN THE 100-117 BEATS PER MINUTE (BPM) RANGE AND EXPERIENCED SYNCOPE. THE PATIENT'S SPOUSE INQUIRED ABOUT DEVICE FUNCTION FOR REGULATING THE HEART RATE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE BRADY AND TACHYCARDIA FUNCTION OF THE DEVICE AND REFERRED THE PATIENT TO THE PHYSICIAN FOR FOLLOW UP. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33662 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening