MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-08-20 for VOCARE BLADDER SYSTEM 1640 NA manufactured by Finetech Medical Ltd..
[218723]
The patient was implanted with the vocare bladder system in 1997. Patient contacted physician to report "fluctuating" results with the vocare system. The patient had an infection of the cervical spine, and was believed to have developed an infection at or near l1, l2. The pt may also have experienced a collapse of l2. Mri revealed vocare electrodes were intact with no sign of infection, and that the pt had l1, l2 vertebral destruction with an l2 diskitis and fluid collection. The poor response to stimulation may have been attributed to nerve compression. The relationship between the patient's condition and the device is unclear. Follow up will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2001-00028 |
| MDR Report Key | 347731 |
| Report Source | 05 |
| Date Received | 2001-08-20 |
| Date of Report | 2001-08-20 |
| Date of Event | 2000-09-21 |
| Date Added to Maude | 2001-08-22 |
| 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 | MICHAEL SOUTHWORTH, DIRECTOR |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOCARE BLADDER SYSTEM |
| Generic Name | IMPLANTABLE NEUROSTIMULATION DEVICE |
| Product Code | GZC |
| Date Received | 2001-08-20 |
| Model Number | 1640 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| 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 | 337049 |
| Manufacturer | FINETECH MEDICAL LTD. |
| Manufacturer Address | 13 TEWIN CT. WELYN GARDEN CITY HERTFORDSHIRE UK |
| Baseline Brand Name | VOCARE BLADDER SYSTEM |
| Baseline Generic Name | IMPLANTABLE NEUROSTIMULATION DEVICE |
| Baseline Model No | 1640 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-08-20 |