BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTATRON

    MDR report key: 270953 · Received March 22, 2000

    Report

    Report Number
    1287394-2000-00055
    Event Type
    Injury
    Date Received
    March 22, 2000
    Date of Event
    February 28, 2000
    Report Date
    March 22, 2000
    Manufacturer
    EDAP TECHNOMED, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 2/28/2000, AN 80 YR OLD MALE WITH A HISTORY OF CARDIAC PROBLEMS UNDERWENT A TUMT FOR BPH. MAC ANESTHESIA WAS BEING ADMINISTERED BY CRNA VIA IV AND MASK. APPROX 20 MINS INTO THE TUMT TREATMENT, THE PT BECAME RESTLESS, AND THEN WENT INTO CARDIAC ARREST. TREATMENT WAS STOPPED. PTS BP BOTTOMED OUT. CPR WAS STARTED FOLLOWED BY DEFFIBRILLATION. PT RECOVERED AND WAS TAKEN BY HELICOPTER TO ANOTHER HOSP. PT WAS RELEASED TO GO HOME 3 DAYS LATER. PT IS CURRENTLY DOING WELL. IN A FOLLOW-UP DISCUSSION WITH THE TREATING PHYSICIAN, DR SAID THAT THE PT'S RECTAL TEMP INCREASED QUICKLY DURING THE TUMT. THE PT BEGAN TO MOVE HIS ARMS. PULSE DROPPED FROM 70 TO 35 BPM. THEY BELIEVED THE PT WAS IN CARDIAC ARREST. DR SAYS THEY CAN NOT DRAW ANY CONCLUSION AS TO THE CAUSE OF THE INCIDENT. PHYSICIAN STATED THAT IT COULD HAVE BEEN A COMBINATION OF ANESTHESIA AND TUMT OR THAT THE CHANGE IN RECTAL TEMP COULD HAVE CAUSED A VASO-VAGAL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTATRON TRANSURETHRAL MICROWAVE TREATMENT DEVICE FOR BPH MEQ EDAP TECHNOMED, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening