MalfunctionGZC
VOCARE BLADDER SYSTEM
Received Nov 6, 2006 · Event occurred Nov 1, 2006
Report 9617096-2006-00004 · MDR key 780446
Device
Generic name
Bladder Controller
Manufacturer
Finetech MedicalModel number
1637-1Catalog number
*
Lot number
*
Product problems
- Explanted
- Failure, intermittent
- Replace
Patient
Not reported
- Surgical procedure, repeated
Narrative
Description of Event or Problem
NDI MEDICAL 01-NOVEMBER-2006: REC'D AN EMAIL FROM DR. STATING THAT THE USER IS SCHEDULED TO HAVE THE IMPLANTABLE RECEIVER STIMULATOR REPLACED. DR. WAS CONTACTED TO OBTAIN ADD'L INFO. 3-NOVEMBER-2006: DR. STATES THAT IMPLANTABLE RECEIVER IS WORKING INTERMITTENTLY.