MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-08-20 for FREEHAND SYSTEM 1060 NA manufactured by Neurocontrol Corporation.
[243991]
The freehand implantable receiver stimulator (irs) was used intraoperatively for lower extremity under an investigational protocol. Patient has an apparent "spasm like" jerking of the leg which is intermittent. Surface potential measurement testing has been performed. Based on the observation and testing performed, irs failure is suspect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2001-00026 |
| MDR Report Key | 348447 |
| Report Source | 06 |
| Date Received | 2001-08-20 |
| Date of Report | 2001-08-20 |
| Date of Event | 2001-07-30 |
| Date Mfgr Received | 2001-07-30 |
| Date Added to Maude | 2001-08-24 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEHAND SYSTEM |
| Generic Name | IMPLANTABLE RECEIVER STIMULATOR |
| Product Code | GZC |
| Date Received | 2001-08-20 |
| Model Number | 1060 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 337767 |
| Manufacturer | NEUROCONTROL CORPORATION |
| Manufacturer Address | 8333 ROCKSIDE ROAD VALLEY VIEW OH 44125 US |
| Baseline Brand Name | FREEHAND SYSTEM |
| Baseline Generic Name | IMPLANTABLE RECEIVER STIMULATOR |
| Baseline Model No | 1060 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-08-20 |