BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1944681 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-21880
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 8, 2010
    Report Date
    August 29, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A SHOCK IMPEDANCE MEASUREMENT OF LESS THAN 20 OHMS WAS DETECTED ON THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD VIA THE LATITUDE PATIENT MONITORING SYSTEM. HOWEVER, A REVIEW OF THE DATA STORED IN THE LATITUDE SYSTEM SHOWED NO VALUE OF LESS THAN 20 OHMS. NO ADVERSE PATIENT EFFECTS OBSERVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED THAT THIS IS A DEVICE SPECIFIC ISSUE, NOT A LEAD ISSUE.

    Description of Event or Problem · 1

    SUBSEQUENTLY, IT WAS REPORTED THAT THIS PATIENT AND LEAD WERE EVALUATED BY THE FOLLOWING PHYSICIAN AND ALL IMPEDANCE MEASUREMENTS REMAINED STABLE AND WITHIN NORMAL LIMITS.

    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 60 YR N119| T165| 0184| 4135| 4592