MalfunctionIWI
I-125 SEEDS
Received Sep 30, 1998 · Event occurred Aug 27, 1998
Report 2915056-1998-00002 · MDR key 194220
Device
Generic name
Implantable Radiation Source
Manufacturer
Nycomed AmershamModel number
*Catalog number
*
Lot number
W81766 AND W81871
Product problems
- Migration or Expulsion of Device
Patient
72 YR
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
A 72 YEAR-OLD MALE UNDERWENT AN I-125 SEED IMPLANTATION. THE PT UNDERWENT THE IMPLANTATION BECAUSE OF PROSTATE CANCER. NO OTHER MEDICAL HISTORY IS KNOWN. 71 I-125 SEEDS, MODEL #6711, WERE IMPLANTED ON 8/27/98. AN X-RAY WAS TAKEN TO CONFIRM THAT THE SEEDS WERE IN PLACE. UPON COUNTING THE SEEDS, IT WAS DETEMINED THAT THERE WERE ONLY 70 SEEDS AT THE IMPLANTATION SITE. AFTER ANOTHER X-RAY, IT WAS CONFIRMED THAT THE EXTRA SEED HAD MIGRATED TO THE LUNG.