MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-04-20 for VOCARE BLADDER SYSTEM 1904 NA manufactured by Neurocontrol Corp..
[21716402]
This pt was implanted with the neurocontrol vocare bladder system 1996. Initial report suggested that there may be an external equipment problem. The pt was advised to self-catheterize for a week or two. 30 days later it was determined that there was an implantale receiver stimulator (irs) problem that would require revision surgery. A follow-up report will be submitted following the revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2003-00005 |
| MDR Report Key | 454639 |
| Report Source | 04 |
| Date Received | 2003-04-20 |
| Date of Event | 2003-03-28 |
| Date Mfgr Received | 2003-03-28 |
| Date Added to Maude | 2003-04-22 |
| 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 | KATHIE MIZAK |
| 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 STIMULATION FOR BLADDER/BOWEL |
| Product Code | GZC |
| Date Received | 2003-04-20 |
| Model Number | 1904 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Eval'ed by Mfgr | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 443636 |
| Manufacturer | NEUROCONTROL CORP. |
| 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 | 2003-04-20 |