MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-20 for VOCARE BLADDER SYSTEM 1640 NA manufactured by Finetech Medical Ltd..
[240574]
Pt was implanted with the vocare bladder system on july 24, 2001. Pt was able to use the device despite an incomplete rhizotomy performed in conjunction with the device implant surgery, but was advised to undergo an additional surgery to complete the rhizotomy. Pt underwent a successful revision rhizotomy procedure in 2001.
Patient Sequence No: 1, Text Type: D, B5
[22189026]
Patient is unable to use device as intended due to incomplete procedure performed in conjunction with implantation procedure for device. Patient was implanted with the vocare bladder system in 2001. Patient is being scheduled for additional surgery to complete the rhizotomy procedure to ensure that the vocare bladder system can function as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2001-00027 |
| MDR Report Key | 347733 |
| Date Received | 2001-08-20 |
| Date of Report | 2001-08-20 |
| Date of Event | 2001-07-24 |
| 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 | 337051 |
| 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 |