BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRE SINGLE ELECTRODE PROBE

    MDR report key: 1655786 · Received April 7, 2010

    Report

    Report Number
    1319211-2010-00015
    Event Type
    Injury
    Date Received
    April 7, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 31, 2010
    Manufacturer
    ANGIODYNAMICS
    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 LOT NUMBER WAS NOT PROVIDED. A SHIP HISTORY SHOWED THAT THE FOLLOWING LOTS HAD BEEN SHIPPED IN THE LAST 6 MONTHS: 081106 AND 080911. THE COMPLAINT INFO 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: THIS COMPLAINT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED AT THE END OF THE INVESTIGATION. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    SVT - HEART RATE JUMPED TO 176, 40MG OF EZMALOL WAS GIVEN, HEART RATE WENT TO 150-137, AGB (BLOOD GAS) WAS TAKEN, GAVE 6MG OF ADENAZINE. HEART RATE BACK DOWN TO 76. PT WAS BACK TO NORMAL SINUS RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRE SINGLE ELECTRODE PROBE IRE SINGLE ELECTRODE PROBE OHJ ANGIODYNAMICS NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention