FDA Adverse Event Injury Summary report: N

BSD SIGMA 60 APPLICATOR

MDR report key: 386350 · Received March 29, 2002

Report

Report Number
MW1024576
Event Type
Injury
Date Received
March 29, 2002
Date of Event
March 21, 2002
Report Date
March 29, 2002
Manufacturer
BSD MEDICAL CORP
Product Code
LNB
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

PT HAS LOCALLY ADVANCED, RADIATION AND HORMONE REFRACTORY, PROSTATE CANCER. THEY PRESENTED WITH A VERY LARGE TUMOR IN THE PROSTATE THAT INVADED AND DESTROYED THE RECTUM AND URINARY BLADDER. PT HAD EVIDENCE OF FISTULA BETWEEN THE RECTUM AND BLADDER PRIOR TO TREATMENT. PT WAS ENROLLED ON PROTOCOL # DRUG 89-002 AND TREATED WITH RE-IRRIDATION AND HYPERTHERMIA WHICH WAS COMPLETED FIVE MOS PREVIOUSLY. PT'S TUMOR RESPONSE WAS SLOW AND CONSEQUENT TO THE TUMOR-RELATED FISTULA OF THE RECTUM PT UNDERWENT A COLOSTOMY IN 2001, IN ANOTHER STATE. PT HAD BEEN DOING WELL UNTIL LAST WEEK WHEN THEY INFORMED RPTR, ON THE TELEPHONE, OF THE DEVELOPMENT OF A URINARY FISTULA INTO THE RECTUM. PT IS ENROLLED IN A GENE THERAPY PROTOCOL FOR REFRACTORY PROSTATE CANCER AND IS BEING FOLLOWED THERE. PT WILL BE UNDERGOING A URETERAL HOOK-UP PROCEDURE TO THE COLOSTOMY IN 2002. PT'S REPEAT CT SCANS DONE HAVE REVEALED SIGNIFICANT TUMOR SHRINKAGE AND PT'S SERUM PSA HAS ALSO DECREASED FROM 65 NG/ML PRIOR TO TREATMENT TO 15 NG/ML AT THE PRESENT TIME. THE DEVELOPMENT OF A FISTULA IN THIS PT IS TUMOR-RELATED AS LARGE PROSTATE TUMOR HAD INVADED THE RECTUM AND URINARY BLADDER PRIOR TO THERAPY. INITIALLY PT DEVELOPED THE FISTULA DUE TO PERSISTENT TUMOR AND TUMOR DESTRUCTION OF THE RECTUM AND BLADDER. HOWEVER, NOW THE TUMOR IS SHOWING EVIDENCE OF SHRINKAGE (CT SCAN AND SERUM PSA RESPONSE) AND THIS IS GIVING RISE TO THE URINARY FISTULA. PTS WITH LARGE TUMORS THAT INVADE INTO ADJACENT ORGANS, ARE ALWAYS AT A RISK FOR FISTULA FORMATION EITHER BECAUSE OF TUMOR-PROGRESSION OR TUMOR-SHRINKAGE AFTER EFFECTIVE THERAPY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BSD SIGMA 60 APPLICATOR HYPERTHERMIA LNB BSD MEDICAL CORP * *

Patients

Seq Age Sex Outcome Treatment
1 73 YR Required Intervention RADIATION THERAPY 2001-2001.