BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2153614 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06435
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 9, 2011
    Report Date
    May 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED LOW SHOCK IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS ON A COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT ISOMETRICS AND POCKET MANIPULATION WERE PERFORMED AND THEY WERE UNABLE TO RECREATE THE ISSUE. THE PHYSICIAN INDICATED THAT HE WILL CONTINUE TO MONITOR THE PATIENT AS THERE WAS ONLY ONE OUT OF RANGE MEASUREMENT.

    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 82 YR (B)(4)| 6949| 5594| 7288| MISMATCH| N119