MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2001-06-13 for FINETECH-BRINDLEY SARS EXTERNAL TRANSMITTER (U.S.=1636-1) manufactured by Finetech Medical Ltd.
[18554868]
Pt was implanted with the finetech-brindley sacral anterior root stimulator (sars) as part of a u. S. Clinical trial in 1997. In 2001 the pt reported that the external control unit was not functioning correctly. A replacement external unit was sent to the pt but did not correct the problem and a new transmitter block and flasher tester was sent to further isolate the problem. The replacement transmitter block restored the foot movement and is now working for the bowels. However, the pt is still not getting urine out. The pt's bladder may have become overstretched when the device initially malfunctioned. The pt's physician has stated there is a good change the the bladder will recover its ability the contract and respond to the "sars" device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2001-00018 |
| MDR Report Key | 337277 |
| Report Source | 05,07 |
| Date Received | 2001-06-13 |
| Date of Report | 2001-05-14 |
| Date of Event | 2001-05-14 |
| Date Mfgr Received | 2001-05-14 |
| Date Added to Maude | 2001-06-15 |
| 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 SARS EXTERNAL TRANSMITTER |
| Generic Name | IMPLANTABLE NEUROSTIMULATION DEVICE |
| Product Code | GZC |
| Date Received | 2001-06-13 |
| Model Number | (U.S.=1636-1) |
| 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 | 326584 |
| Manufacturer | FINETECH MEDICAL LTD |
| Manufacturer Address | 13 TEWIN CT. WELYN GARDEN CITY HERTFORDSHIRE UK |
| Baseline Brand Name | FINETECH-BRINDLEY SARS EXTERNAL TRANSMITTER |
| Baseline Generic Name | IMPLANTABLE NEUROSTIMULATION DEVICE |
| Baseline Model No | (U.S.=1636-1) |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2001-06-13 |