BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3223626 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-09465
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 31, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE EVALUATION, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH SHOCK LEAD IMPEDANCE MEASUREMENTS OF GREATER THAN 200 OHMS. NO NOISE OR STORED EPISODES WERE OBSERVED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED TO PERFORMED ISOMETRICS AND DISCUSSED ELECTROMAGNETIC INTERFERENCE (EMI) AS A CAUSE. THE HEALTH CARE PROFESSIONAL (HCP) WAS TO PERFORM THE RECOMMENDED TESTING. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED AND INDICATED THAT THE PHYSICIAN TRIED TO PUT IN ANOTHER RV LEAD BUT WERE UNSUCCESSFUL BECAUSE THE PATIENT HAD THREE LEADS IN AND IT WAS TIGHT IN THE SUPERIOR VENA CAVA. THE PHYSICIAN DECIDED TO TURN OFF THE TACHY MODE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322667 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 5054| 4518| MISMATCH| N118| 0184| 5076