BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRE SINGLE ELECTRODE PROBE

    MDR report key: 1639493 · Received March 19, 2010

    Report

    Report Number
    1319211-2010-00010
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    February 22, 2010
    Report Date
    March 17, 2010
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    OHJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE COMPLAINT INFO WAS FORWARDED TO PRONET. PRONET REVIEWED THE POSSIBLE LOT HISTORY RECORDS AND FOUND NO VARIANCES RELATED TO THIS EVENT WERE OBSERVED. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVAL. CONCLUSION: THE EXACT CAUSE OF THE COMPLAINT IS UNK. EPISODES OF ATRIAL FIBRILLATION MAY LAST A FEW HOURS OR SEVERAL DAYS. MOST PEOPLE WITH ATRIAL FIBRILLATION HAVE SOME STRUCTURAL ABNORMALITIES OF THE HEART RELATED TO SUCH CONDITIONS AS HEART DISEASE OR HIGH BLOOD PRESSURE. OTHER FACTORS THAT MAY CONTRIBUTE TO ATRIAL FIBRILLATION INCLUDE HEART VALVE DISORDER, HYPERTHYROIDISM OR HEAVY ALCOHOL CONSUMPTION. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION REQUIRED AT THIS TIME. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    PT EXPERIENCED TACHYCARDIA WENT INTO ATRIAL FIBRILLATION DURING THE DELIVERY OF THE IRE FOR THE SECOND LESION LOCATED IN THE DOME OF THE LIVER. THE CLOSEST ACTIVE PORTION OF AN ELECTRODE WAS LESS THAN OR EQUAL TO 5MM FROM THE PERICARDIUM. ANESTHESIA PERFORMED MULTIPLE INTERVENTIONS TO CORRECT THE ARRHYTHMIA; BETA BLOCKER, LIDOCAINE, CORTIZOME, CARDIOAVERSION (20/50/70 JOULES). CARDIOAVERSION AT 70 JOULES RESOLVED THE ARRHYTHMIA. ANESTHESIA CHECKED FOR ELECTROLYTE ABNORMALITIES AND DID NOT FIND ANY. PT HAS NORMAL EKG RHYTHM AND RECOVERED FROM ANESTHESIA FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRE SINGLE ELECTRODE PROBE IRE SINGLE ELECTRODE PROBE OHJ ANGIODYNAMICS, INC. 00810709

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention