BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1950803 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22705
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 21, 2010
    Report Date
    September 15, 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

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    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

    SUBSEQUENT INFORMATION INDICATES THAT IT WAS AN ISOLATED OUT OF RANGE IMPEDANCE MEASUREMENT AND THE PHYSICIAN PLANS TO CONTINUE TO MONITOR. IT WAS ALSO REPORTED THAT THE PATIENT'S RV LEAD WAS A COMPETITOR'S PRODUCT; HOWEVER ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REFERENCED ABOVE IS IN-SERVICE AS A SHOCKING LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT, MEASURING LESS THAN 20 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN 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 77 YR 4195| A155| N119| 4087| 0185