BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3211512 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-10033
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    January 20, 2013
    Report Date
    May 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THAT THE RV LEAD WAS FULLY INSERTED BASED ON THE MARKING INSIDE THE LEAD BARREL. ALL SEAL PLUGS WERE PRESENT, HOWEVER, THE DF-1 MINUS SEAL PLUG WAS LIFTED AND THE DF-1 MINUS SET SCREW WAS MISSING. FURTHER TESTING CONFIRMED THE DEVICE TO PASS ALL ELECTRICAL TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM DISPLAYED NOISE, RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). ADDITIONALLY, INCREASED RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS WERE OBSERVED. A REVISION PROCEDURE WAS PERFORMED AND THIS DEVICE WAS EXPLANTED. DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL (HIGH VOLTAGE) SET SCREW APPEARED TO BE POPPED UP. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311309 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4549| 5076| 0158| N119