FDA Adverse Event
Injury
Summary report: N
VOCARE BLADDER SYSTEM
MDR report key: 302597
·
Received November 1, 2000
Report
- Report Number
- 1530440-2000-00010
- Event Type
- Injury
- Date Received
- November 1, 2000
- Date of Event
- October 3, 2000
- Manufacturer
- NEUROCONTROL CORP.
- Product Code
- GZC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT WAS IMPLANTED WITH THE VOCARE BLADDER SYSTEM IN 2000 IN THE US. LATER THAT MONTH THE PT HAD THEIR STITCHES REMOVED AT THE INCISION SITE. AT THIS TIME IT WAS OBSERVED THAT THE PT HAD DEVELOPED A SEROMA (NOT INFLAMMED) AND HAD A TEMPERATURE OF 102. PT WAS ADMITTED TO HOSP FOR A COMPLETE FEVER WORKUP AND WAS PUT ON ANTIBIOTICS. DURING HOSP STAY, PT'S FEVER WENT DOWN, HOWEVER, WAS TESTED POSITIVE FOR A URINARY TRACT INFECTION AND WAS TREATED. CULTURES WERE TAKEN FROM THE AREA OF INCISION AND WERE LATER FOUND TO BE POSITIVE. IT HAS NOT BEEN DETERMINED IF THE IMPLANT POCKET IS INFECTED OR JUST THE SURFACE OF THE SKIN. CURRENTLY THE PT IS STILL BEING TREATED WITH ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOCARE BLADDER SYSTEM | IMPLANTABLE NEUROSTIMULATION DEVICE | GZC | NEUROCONTROL CORP. | 1640-1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |