MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-21 for FREEHAND SYSTEM 1060-2 NA manufactured by Neurocontrol Corporation.
[228115]
A pt was implanted with the freehand system hand grasp neuroprosthesis in 2001. Two months later, the pt reported that experiencing difficulty achieving coupling between the external control unit and the implantable receiver-stimulator (irs) implanted in the pt's chest. There is no pt injury. The pt is "heavy chested" and coupling is highly sensitive to pt position, indicating that the irs was likely implanted too deeply. A revision surgery is being planned to reposition the irs at a more shallow depth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2001-00021 |
| MDR Report Key | 338991 |
| Date Received | 2001-06-21 |
| Date of Report | 2001-05-22 |
| Date of Event | 2001-05-22 |
| Date Mfgr Received | 2001-05-22 |
| Device Manufacturer Date | 2000-10-01 |
| Date Added to Maude | 2001-06-27 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEHAND SYSTEM |
| Generic Name | HAND GRASP NEUROPROSTHESIS |
| Product Code | GZC |
| Date Received | 2001-06-21 |
| Model Number | 1060-2 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2002-10-01 |
| 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 | 328295 |
| Manufacturer | NEUROCONTROL CORPORATION |
| Manufacturer Address | 8333 ROCKSIDE ROAD VALLEY VIEW OH 44125 US |
| Baseline Brand Name | FREEHHAND SYSTEM |
| Baseline Generic Name | NEUROMUSCULAR STIMULATOR IMPLANT |
| Baseline Model No | 1060-2 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | FREEHAND SYSTEM IMPLANTABLE RECEIVER STIMULATOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P9500 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-06-21 |