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 1635-1 NA manufactured by Neurocontrol Corp.
[16787776]
In 2002, this pt reported that batteries in vocare bladder system ecu require charging more frquently than weekly, and that pt had not observed "normal leg movement" for more than one month. The pt also reported some spinal deformity, and that pt was taking several pain medications. The ecu was returned and tested, and does not appear to have malfunctioned, and a replacement device showed similar results. Subsequent info received from a consulting urologist indicates that this pt experienced spinal dislocation of l1 and l2 and that pt vocare device is not producing voiding, probably due to nerve compression rendering the nerves unresponsive to stimulation. The pt had fixation hardware removed a considerable time before implantation of the vocare system, and the disclocation has been attributed primarily to the hardware removal. However, the laminectomy for the rhizotomy procedure that is performed in conjucntion with device implantation may have contributed to the spinal instability resulting in the dislocation. Follow up info will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00003 |
| MDR Report Key | 380170 |
| Report Source | 05 |
| Date Received | 2002-03-01 |
| Date of Report | 2002-02-28 |
| Date Mfgr Received | 2002-02-25 |
| Date Added to Maude | 2002-03-08 |
| 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 | 1635-1 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 369216 |
| Manufacturer | NEUROCONTROL CORP |
| Manufacturer Address | 9333 ROCKSIDE RD VALLEYVIEW OH 44125 US |
| Baseline Brand Name | VOCARE BLADDER SYSTEM |
| Baseline Generic Name | NEUROMUSCULAR STIMULATOR |
| Baseline Model No | 1635-1 |
| Baseline Catalog No | 1635-1 |
| Baseline ID | NA |
| Baseline Device Family | IMPLANTABLE RECEIVER STIMULATOR |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-03-01 |