BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3210143 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09772
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 7, 2013
    Report Date
    November 6, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE ALERT FOR HIGH, OUT OF RANGE, SHOCK LEAD IMPEDANCE HAS REOCCURRED. AT THIS TIME, THE PLAN CONTINUES TO BE TO MONITOR. THE SYSTEM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING SYSTEM TRANSMITTED THAT HIGH, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCES FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD WERE DETECTED. THE PATIENT WAS EVALUATED IN THE CLINIC AND MEASUREMENTS WERE NORMAL. AT THIS TIME, THE CLINIC WAS GOING TO CONTINUE TO MONITOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310587 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR C154DWK| N119| 4194| MISMATCH| 5076| 6949