MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-11-15 for VOCARE BLADDER SYSTEM 1904 NA manufactured by Neurocontrol Corporation.
[252359]
This patient was implanted with the vocare bladder system in 1999. Recently the patient complained of an inability to empty their bladder using the device and believed it to be attributable to ecu battery problems. A replacement ecu was provided, which was reportedly being used successfully initially. However, it was subsequently reported that the patient also could not empty using the replacement ecu, and the patient's clinican determined that the patient likely had a distended bladder. The patient used a catheter as an alternative to the vocare for 1-2 weeks, then returned to using the vocare with modified ecu settings, and is now experiencing no problems emptying. This report is considered complete and no follow-up report is planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00014 |
| MDR Report Key | 427953 |
| Report Source | 05 |
| Date Received | 2002-11-15 |
| Date of Report | 2002-10-16 |
| Date of Event | 2002-09-01 |
| Date Mfgr Received | 2002-10-16 |
| Date Added to Maude | 2002-11-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL SOUTHWORTH |
| Manufacturer Street | 8333 ROCKSIDE ROAD |
| Manufacturer City | VALLEY VIEW OH 44125 |
| Manufacturer Country | US |
| Manufacturer Postal | 44125 |
| Manufacturer Phone | 2169120101 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOCARE BLADDER SYSTEM |
| Generic Name | SACRAL ANTERIOR ROOT STIMULATOR FOR BLADDER/BOWEL |
| Product Code | GZC |
| Date Received | 2002-11-15 |
| Returned To Mfg | 2002-10-18 |
| Model Number | 1904 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 416972 |
| Manufacturer | NEUROCONTROL CORPORATION |
| Manufacturer Address | 8333 ROCKSIDE ROAD VALLEY VIEW OH 44125 US |
| Baseline Brand Name | VOCARE BLADDER SYSTEM |
| Baseline Generic Name | SACRAL ANTERIOR ROOT STIMULATOR FOR BLADDER/BOWEL |
| Baseline Model No | 1904 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-11-15 |