MalfunctionGZC
VOCARE BLADDER SYSTEM
Received Nov 6, 2006 · Event occurred Oct 26, 2006
Report 9617096-2006-00003 · MDR key 780455
Device
Generic name
Bladder Controller
Manufacturer
Finetech MedicalModel number
1637-1Catalog number
*
Lot number
*
Product problems
- Explanted
- Failure, intermittent
- Replace
Patient
*
- Surgical procedure, repeated
Narrative
Description of Event or Problem
NDI MEDICAL 01-NOVEMBER-2006: REC'D AN EMAIL FROM DR STATING THAT THE USER HAD MINOR SURGERY TO REPLACE THE IMPLANTED RECEIVER AND WENT HOME THE NEXT DAY WITH A FUNCTIONING SYSTEM. DR. WAS CONTACTED TO OBTAIN ADD'L INFO. 3-NOVEMBER-2006: DR. STATES THAT IMPLANTABLE RECEIVER WAS WORKING INTERMITTENTLY AND COULD BE MADE TO FUNCTION OR CEASE FUNCTION BY PRESSING ON IT.
Additional Manufacturer Narrative
DR. HAS INDICATED THAT THE EXPLANTED RECEIVER WILL BE RETURNED FOR EVAL AFTER STERILIZING.