MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-05-24 for SACRAL ANTERIOR ROOT STIMULATOR (IN US=1635-1) NA manufactured by Finetech Medical Ltd..
[189150]
Physician reports pt has been diagnosed with a failure of the finetech-brindley sacral anterior root stimulator implantable receiver stimulator (irs). There are plans to perform a replacement surgery of the irs. Follow-up info will be provided when available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2001-00016 |
| MDR Report Key | 334607 |
| Report Source | 07 |
| Date Received | 2001-05-24 |
| Date of Report | 2001-04-25 |
| Date Mfgr Received | 2001-04-25 |
| Date Added to Maude | 2001-05-29 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SACRAL ANTERIOR ROOT STIMULATOR |
| Generic Name | IMPLANTABLE NEUROSTIMULATION DEVICE |
| Product Code | GZC |
| Date Received | 2001-05-24 |
| Model Number | (IN US=1635-1) |
| 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 | I |
| Device Sequence No | 1 |
| Device Event Key | 323952 |
| Manufacturer | FINETECH MEDICAL LTD. |
| Manufacturer Address | 13 TEWIN CT. WELYN GARDEN CITY HETFORDSHIRE UK |
| Baseline Brand Name | SACRAL ANTERIOR ROOT STIMULATOR |
| Baseline Generic Name | IMPLANTABLE NEUROSTIMULATION DEVICE |
| Baseline Model No | (IN US=1635-1) |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-05-24 |