BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1771483 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12659
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    May 11, 2010
    Report Date
    June 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), A NON-BOSTON SCIENTIFIC LEFT VENTRICULAR (LV) LEAD WOULD NOT GO ALL THE WAY INTO THE DEVICE HEADER, AND THE SET SCREW COULD NOT BE TIGHTENED DOWN. THE PHYSICIAN WAS EVENTUALLY ABLE TO GET THE LEAD IN AFTER LUBRICATING THE SEALING RINGS, AND TIGHTEN THE SET SCREW. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR MISMATCH| 1861| 4554| 4469| 0147| N119