FDA Adverse Event
Injury
Summary report: N
VOCARE BLADDER SYSTEM
MDR report key: 444495
·
Received February 26, 2003
Report
- Report Number
- 1530440-2003-00003
- Event Type
- Injury
- Date Received
- February 26, 2003
- Report Date
- January 27, 2003
- Manufacturer
- NEUROCONTROL CORP
- Product Code
- GZC
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT WAS IMPLANTED WITH VOCARE BLADDER SYSTEM BUT REPORTED REDUCED FUNCTION. EVAL OF THE PT SHOWS OVER-DISTENDED BLADDER VOLUME 1200ML) WHICH IS REPORTED DUE TO INFREQUENT USE OF THE DEVICE. THIS PT HAS A C4 SPINAL CORD INJURY AND REQUIRES ASSISTANCE TO USE THIS DEVICE AND HAS HAD SEVERAL EPISODES. RECOVERY IS EXPECTED. THIS REPORT IS CONSIDERED COMPLETE AND NO FOLLOW UP IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOCARE BLADDER SYSTEM | SACRAL ANTERIOR ROOT STIMULATOR FOR BLADDER/BOWEL | GZC | NEUROCONTROL CORP | 1904 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |