BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2170214 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09644
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    March 16, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE REMOTE MONITORING SYSTEM DETECTED ANOTHER ALERT DUE TO HIGH SHOCK IMPEDANCES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED OUT OF RANGE SHOCK IMPEDANCES OF GREATER THAN 125 OHMS. UPON REVIEW OF THE PAST MEASUREMENTS, IT WAS NOTED THAT THERE WERE SOME OUT OF RANGE IMPEDANCES AT IMPLANT; HOWEVER, THE MEASUREMENTS HAD STABILIZED TO 75 TO 80 OHMS. TECHNICAL SERVICES (TS) DISCUSSED A POSSIBLE CONNECTION ISSUE OR LEAD FRACTURE. THIS WOULD BE DISCUSSED FURTHER WITH THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 81 YR 4469| N119| H210| 4047| 0184| 4543| 4538