BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3210945 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08365
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    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

    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 RIGHT VENTRICULAR (RV) LEAD AND DEVICE DISPLAYED A HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT THAT WAS DETECTED VIA THE PATIENT'S HOME REMOTE MONITORING SYSTEM. THE PATIENT WAS TO BE SEEN IN CLINIC FOR FOLLOW UP. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) INDICATED THAT THEY WERE NOT AWARE OF ANY FURTHER INFORMATION REGARDING THIS CLINICAL OBSERVATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309649 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR N119| 0180| 1688TC| MISMATCH