BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3052649 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04329
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 26, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN SCHEDULED THE PATIENT FOR NON-INVASIVE PROGRAMMED STIMULATION (NIPS) FOR A DATE IN THE FUTURE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEEN FOR AN IN-CLINIC FOLLOW UP. THE PHYSICIAN ELECTED TO PERFORM DEFIBRILLATION THRESHOLD (DFT) TESTING AND THE PATIENT WAS SUCCESSFULLY CONVERTED WITH A 21 JOULE SHOCK. SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED TO BE 41 OHMS. THE PHYSICIAN WAS SATISFIED AND WILL CONTINUE TO MONITOR THE SYSTEM. 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) AND ANOTHER MANUFACTURER'S IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. OUT OF RANGE MEASUREMENTS WERE UNABLE TO BE RECREATED DURING IN CLINIC TESTING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED ADDITIONAL TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156800 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization 4968| N119| 6947| MISMATCH| 4592| 4076| 4543