BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2053304 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03999
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THE PATIENT WITH THIS DEVICE RECEIVED 10 SHOCKS. AN INTERROGATION OF DEVICE HISTORY SHOWED THE PATIENT IN SVT AROUND 140 BPM. THE DEVICE CHECK PROVED NORMAL IN REGARDS TO SENSING AND IMPEDANCE MEASUREMENTS. THE PHYSICIAN EXPRESSED CONCERN WITH THE DEVICE MEMORY DATA, AS THE EPISODES HAD BEEN OVERWRITTEN. ADDITIONALLY, THE PHYSICIAN COMMENTED ON THE APPLICATION OF THE DEVICE APPLIED DISCRIMINATORS AND THEIR LIMITED PROGRAMMABLE FUNCTION. NO SPECIFIC ADVERSE PATIENT EFFECTS WERE REPORTED AND THE DEVICE WAS REPROGRAMMED FOR THIS PATIENT'S SPECIFIC CARDIAC RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N108

    Patients

    Seq Age Sex Outcome Treatment
    1