BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONCOBIONICS SYSTEM

    MDR report key: 1713286 · Received June 3, 2010

    Report

    Report Number
    1319211-2010-00026
    Event Type
    Other
    Date Received
    June 3, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 27, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE REPORTED COMPLAINT STATES A PT CONDITION AND NOT A PRODUCT FAILURE. BASED ON THE REPORTED COMPLAINT, THE IRE SINGLE PROBE DEVICE FUNCTIONED PROPERLY. THE ARRHYTHMIAS WERE TRANSIENT AND WERE SELF RESOLVED. THE EXACT CAUSE OF THE COMPLAINT IS UNK. THE REPORTED COMPLAINT COULD HAVE BEEN CAUSED FROM THE GENERAL ANESTHESIA, THE MUSCLE BLOCK, PATIENT CONDITION OR THE IRE PROCEDURE. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION AT THIS TIME. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    DURING THE IRE PULSE DELIVERY, SHORT EPISODES OF ARRHYTHMIA WERE OBSERVED ON EKG MONITOR OF THE ACCUSYNC WHICH LASTED FOR 1-4 HEARTBEATS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOBIONICS SYSTEM NANOKNIFE IRE SINGLE ELECTRODE PROBE OAB ANGIODYNAMICS NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other