BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2911772 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00212
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A PHYSICIAN WAS DOING NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WITH A PATIENT. THE PHYSICIAN WAS TRYING TO DO PROGRAMMED ELECTRICAL STIMULATION (PES) WITH TACHY THERAPY OFF BUT NOTED EVERYTHING WAS GREYED OUT. THE PHYSICIAN WAS TRYING TO INDUCE VENTRICULAR TACHYCARDIA (VT) AND ABLATE AND NOT HAVE THE PATIENT GET A SHOCK. BOSTON SCIENTIFIC TECHNICAL SERVICES ADVISED THAT THE TACHY MODE NEEDS TO BE ON MONITOR PLUS THERAPY FOR SAFETY REASONS AND TO PROVIDE THERAPY IF THE PATIENT IS INDUCED. AS OF TODAY, THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18688 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R