MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-06-14 for FINETECH-BRINDLEY SACRAL ANTERIOR ROOT STIMULATOR UNK NA manufactured by Finetech Medical Ltd..
[228879]
Patient was implanted with the finetech-brindley sacral anterior root stimulator in another country in 1991. The system was not working and a revision surgery was performed. After this surgery, the system was still not working and a second revision surgery had been scheduled for 2001. Follow-up information will be provided when available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2001-00020 |
| MDR Report Key | 337300 |
| Report Source | 07 |
| Date Received | 2001-06-14 |
| Date of Report | 2001-05-15 |
| Date Mfgr Received | 2001-05-15 |
| Date Added to Maude | 2001-06-18 |
| 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 | PAMELA THOMAS |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FINETECH-BRINDLEY SACRAL ANTERIOR ROOT STIMULATOR |
| Generic Name | IMPLANTABLE NEUROSTIMULATION DEVICE |
| Product Code | GZC |
| Date Received | 2001-06-14 |
| Model Number | UNK |
| 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 | 326604 |
| Manufacturer | FINETECH MEDICAL LTD. |
| Manufacturer Address | 13 TEWIN CT. WELYN GARDEN CITY HERTFORDSHIRE UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-06-14 |