BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2780032 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12016
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    August 21, 2012
    Report Date
    February 19, 2013
    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

    --

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT ALL SHOCK IMPEDANCE MEASUREMENTS WERE NORMAL BEFORE AND AFTER THE ONE OUT OF RANGE MEASUREMENT. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    ADDITIONAL EVIDENCE WAS RECEIVED THAT THE LOW SHOCK IMPEDANCE LEVELS DETECTED DURING THIS EVENT WERE NOT A LEAD ISSUE, BUT IN FACT RELATED TO THIS PULSE GENERATOR. NO OTHER INFORMATION HAS BEEN RECEIVED ABOUT THE EVENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED SHOCK IMPEDANCES OF LESS THAN 20 OHMS. 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 75 YR MISMATCH| N119| 5076| 0158