BEUDAMED
    FDA Adverse Event Death Summary report: N

    IRE SINGLE ELECTRODE PROBE

    MDR report key: 1658001 · Received April 9, 2010

    Report

    Report Number
    1319211-2010-00017
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    March 13, 2010
    Report Date
    April 8, 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 CATALOG NUMBER AND LOT NUMBER WERE NOT REPORTED. A SHIP HISTORY WAS CONDUCTED AND SHOWED THE FOLLOWING LOTS HAD BEEN SHIPPED TO THE COMPLAINANT: CATALOG NUMBER 20400101 / POSSIBLE LOTS 081106 AND 080911. REVIEW OF RETURNED SAMPLE: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. CONCLUSION: THIS COMPLAINT IS CURRENTLY UNDER FURTHER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    FOR THE FOURTH AND FINAL SEQUENCE, THE PATIENT EXPERIENCED AN EPISODE OF SUPRAVENTRIICULAR TACHYCARDIA (SVT). THE EPISODE WAS OF MODERATE INTENSITY AND WAS CONTROLLED BY DRUG THERAPY AND RESOLVED IN 15-20 MIN. AT THAT TIME THE FOURTH AND FINAL SEQUENCE WAS INITIATED AND COMPLETED WITHOUT INCIDENT. THE PATIENT WAS KEPT OVERNIGHT AND RELEASED TO HOME THE FOLLOWING DAY. THE PATIENT'S FAMILY FELT SHE HAD DETERIORATED OVER THE WEEKEND AND BROUGHT HER BACK 72 HOURS AFTER THE (B) (4) PROCEDURE, AND SHE WAS READMITTED. THE FAMILY HAD TRANSFERRED HER CARE FROM THE HOSPITAL STAFF TO A PRIVATE GROUP OF GASTROENTEROLOGISTS. HE SUGGESTED THAT SHE MAY HAVE HEPATORENAL SYNDROME AND PROPOSED INSERTING A DRAIN INTO THE GALLBLADDER TO ALLEVIATE THE BILIRUBIN ISSUE AND DIALYSIS TO ALLOW RENAL FUNCTION TO SLOWLY RETURN TO NORMAL. HIS PROPOSAL WAS NOT ACCEPTED BY THE OUTSIDE GASTROENTEROLOGISTS AS THEY HAD SUGGESTED THE FAMILY TO CONSIDER HOSPICE. THE PATIENT WAS PLACED ON HOSPICE CARE AND DIED 2 WEEKS LATER (21 DAYS POST (B) (4)).

    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 70 YR Death| R