BEUDAMED
    FDA Adverse Event Death Summary report: N

    IRE SINGLE ELECTRODE PROBE

    MDR report key: 1655768 · Received April 7, 2010

    Report

    Report Number
    1319211-2010-00016
    Event Type
    Death
    Date Received
    April 7, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 31, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OHJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: (B) (4). 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: THIS COMPLAINT IS CURRENTLY UNDER INVESTIGATION. A COPY OF THE AUTOPSY REPORTED HAS BEEN REQUESTED. 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

    (B) (6) I JUST LEARNED TODAY THAT SHE DIED. (B) (6) WE TREATED ALMOST 4 WEEKS AGO AND WHO I DESCRIBED IN PRIOR EMAILS HAD MARKEDLY IMPROVING LIVER FUNCTION AND RENAL FUNCTION. HOWEVER, SHE REMAINED VENTILATOR DEPENDENT FOR OVER 3 WEEKS FOR UNCLEAR REASONS. SHE HAD A PRE-PROCEDURAL ECOG PERFORMANCE STATUS OF 0-1. THERE WAS NO EVIDENCE OF ARDS, OR PULMONARY EDEMA ON CXR. LAST FRIDAY, HER CT SHOWED NO PE NO CT DETECTABLE HEPATIC PULMONARY SHUNTS, AND NO PULMONARY EDEMA. THERE WAS NO EVIDENCE OF DIAPHRAGMATIC INJURY. THERE WAS ONLY A SMALL AMOUNT OF ASCITES AND PLEURAL EFFUSION. THE CAUSE OF HER PULMONARY ISSUES AND VENTILATOR DEPENDENCE ARE UNCLEAR. SHE HAD FAILED SEVERAL ATTEMPTS TO EXTUBATE. THERE WAS A DISCUSSION OF PLACING A TRACHEOTOMY WHICH HER CHILDREN DID NOT SUPPORT. ON MONDAY (B) (6) 2010 SHE WAS EXTUBATED AND TRANSFERRED TO A FLOOR. SHE PASSED AWAY LATER THAT DAY. (B) (6) DIED - 24 DAYS POST OP WHICH IS UNDER THE 30 DAY LIMIT MAKING THIS A PROCEDURAL RELATED DEATH. I DO NOT YET KNOW WHY SHE WAS EXTUBATED, AND WHY SHE DIED. DO NOT KNOW IF SHE HAD AN AUTOPSY. WILL INVESTIGATE OVER THE NEXT FEW DAYS AND LET YOU KNOW.

    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 NA Death| R