FDA Adverse Event
Injury
Summary report: N
VOCARE BLADDER SYSTEM
MDR report key: 448981
·
Received March 19, 2003
Report
- Report Number
- 1530440-2003-00004
- Event Type
- Injury
- Date Received
- March 19, 2003
- Date of Event
- February 21, 2003
- Manufacturer
- NEUROCONTROL CORP.
- Product Code
- GZC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH VOCARE BLADDER SYSTEM IN 2000. ON JANUARY 22, 2003 THE VOCARE BLADDER SYSTEM STOPPED WORKING. PATIENT WAS USING CATHETERIZATION FOR VOIDING. 2 MONTHS LATER SURGERY WAS PERFORMED AND THE ENTIRE DEVICE WAS REPLACED AS THE FAULT IN THE IMPLANT WAS CLOSE TO THE SPINE. THE PATIENT IS NOW USING THE NEW DEVICE. THIS REPORT IS CONSIDERED COMPLETE AND NO FOLLOW-UP REPORT IS ANTICIPATED.
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 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |