BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRE SINGLE PROBE

    MDR report key: 1601401 · Received February 12, 2010

    Report

    Report Number
    1319211-2010-00006
    Event Type
    Injury
    Date Received
    February 12, 2010
    Date of Event
    January 11, 2010
    Report Date
    February 12, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OHJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE COMPLAINT INFORMATION WAS FORWARDED TO (B) (4). (B) (4) REVIEWED THE POSSIBLE LOT HISTORY RECORDS AND FOUND NO VARIANCES RELATED TO THIS EVENT WERE OBSERVED. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. CONCLUSION: THE EXACT CAUSE OF THE COMPLAINT IS UNKNOWN. BRADYCARDIA IS A COMMON SIDE EFFECT ASSOCIATED WITH ANESTHETIC AND VAGUS NERVE STIMULATION. IN THIS REPORTED CASE THE PATIENT HAD 4+ HOURS OF GA AND MUSCLE BLOCKADE AND THE IRE ELECTRODES WERE CLOSE TO BRANCHES OF THE VAGUS NERVE. THIS COMPLAINT TYPE HAS BEEN ADDED TO THE IFU. THIS IFU IS CURRENTLY IN CIRCULATION FOR APPROVAL. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TREND. 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

    BRADYCARDIA, HYPOXIA, ASYSTOLE ADDED FROM AN EMAIL DATED JANUARY 13, 2010 FROM GORDON SINGLE THIS IS AN EXCERPT FROM DR (B) (6) CORRESPONDENCE: "DURING A PREVIOUS RFA UNDER CONSCIOUS SEDATION HE HAD EPISODES OF BRADYCARDIA THAT REQUIRED ATROPINE. THE IRE ELECTRODES WERE CLOSE TO BRANCHES OF THE VAGUS NERVE DURING THE IRE SO I AM ASSUMING WE STIMULATED HIS VAGAL NERVES WHICH OBVIOUSLY LEADS TO THE EXTREME BRADYCARDIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRE SINGLE PROBE NANOKNIFE IRREVERSIBLE ELECTROPORATION OHJ ANGIODYNAMICS 080911

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention