MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-08-30 for VOCARE BLADDER SYSTEM 1904 NA manufactured by Neurocontrol Corp..
[260915]
This pt was implanted with the neurocontrol vocare bladder system in 2001. The physician reported that the pt is very active and began experiencing difficulty using the device after competing in a wheelchair marathon. Pt is still able to use the device, but the physician reports that there may be a broken wire on channel a of the implantable receiver stimulator (irs). A revision surgery is required to confirm and repair the device, which is scheduled for 2002. A follow-up report will be submitted following the revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00009 |
| MDR Report Key | 413988 |
| Report Source | 05 |
| Date Received | 2002-08-30 |
| Date of Report | 2002-07-31 |
| Date Mfgr Received | 2002-07-31 |
| Device Manufacturer Date | 2000-03-01 |
| Date Added to Maude | 2002-09-04 |
| 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 | 2002-08-30 |
| Model Number | 1904 |
| Catalog Number | NA |
| Lot Number | NA |
| 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 | 403027 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE RD. 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 | 2002-08-30 |