BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2910679 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16320
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DEVICE WAS DISPLAYING OUT OF RANGE MEASUREMENTS OF LESS THAN 200 OHMS. THERE WAS A QUESTION WHY THIS WOULD DISPLAY LOW OUT OF RANGE MEASUREMENTS WITH ONE OF THE PORTS PLUGGED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. PER BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOLLOWING A REVIEWED OF THE INFOMATION CONCLUDED THIS IS AN EXPECTED OBSERVATION WITH THE DEVICE WHEN A PORT HAS BEEN PLUGGED AND IS NOT BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18924 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 0180| N119| 4555| 4554| MISMATCH| H210| 0185| 7122| 4542