BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1944760 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20156
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 8, 2010
    Report Date
    May 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, INFORMATION WAS RECEIVED FROM BOSTON SCIENTIFIC MEDICAL RECORDS IDENTIFYING THAT THE CORRECT SERIAL NUMBER FOR THE PRODUCT RELATED TO THIS REPORT IS SERIAL NUMBER (B)(4). THE REPORT HAS BEEN UPDATED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE WITHOUT ANY FURTHER ISSUE. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD EXHIBITED <20 OHMS SHOCK IMPEDANCE MEASUREMENT. THE SUBSEQUENT DEVICE SYSTEM CHECK, INCLUDING A COMMANDED 41 JOULES SHOCK RESULTING IN 44 SLIT, WERE ALL WITHIN NORMAL LIMITS. THE BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT SUSPECTED ELECTROMAGNETIC INTERFERENCE (EMI) MIGHT HAVE CAUSED THE OUT-OF-RANGE SHOCK IMPEDANCE OUTLIER. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS AND NO IMPACT ON CRITICAL THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 4543| 4470| 1860| 0158| N119