MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-03-01 for VOCARE BLADDER SYSTEM 1640-1/1641-1 NA manufactured by Neurocontrol Corp..
[263893]
This patient was implanted with the vocare bladder system in 2002, and experienced high residuals post-implantation. Approximately one month following device implantation, the patient underwent a procedure to reposition the extradural electrode and tie it closer to the nerve root. The response was improved intraoperatively, but poor response was again experienced post-operatively. The same week, another surgery was performed in which a nick in the insulation of the lead was observed. At this time, a new electrode was implanted to replace the malfunctioning electrode. The original electrode was left implanted with the new electrode connected to the implanted stimulator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00002 |
| MDR Report Key | 379542 |
| Report Source | 05 |
| Date Received | 2002-03-01 |
| Date of Report | 2002-02-28 |
| Date of Event | 2002-01-01 |
| Date Mfgr Received | 2002-01-23 |
| Device Manufacturer Date | 2000-03-01 |
| Date Added to Maude | 2002-03-06 |
| 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 | IMPLANTABLE STIMULATOR FOR BLADDER EVACUATION |
| Product Code | GZC |
| Date Received | 2002-03-01 |
| Model Number | 1640-1/1641-1 |
| Catalog Number | NA |
| Lot Number | 1138/1139 |
| ID Number | NA |
| Device Expiration Date | 2002-03-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 368572 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE ROAD VALLEY VIEW OH 44125 US |
| Baseline Brand Name | VOCARE BLADDER SYSTEM |
| Baseline Generic Name | IMPLANTABLE STIMULATOR FOR BLADDER EVACUATION |
| Baseline Model No | 1640-1/1641-1 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-03-01 |