BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2911483 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-17229
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 21, 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

    THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE RECEIVED.

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THROUGH A REMOTE MONITORING SYSTEM THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) TACHY THERAPY WAS PROGRAMMED OFF FOR AN UNKNOWN REASON. THERE WAS NO AVAILABLE INFORMATION IMMEDIATELY AVAILABLE. AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION HAS BEEN SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERAPY WAS INTENTIONALLY TURNED OFF BECAUSE OF PATIENT'S DETERIORATING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17474 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR N119| 4543| 0185| S601| 4136