MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-06-28 for FREEHAND SYSTEM 1060-1 NA manufactured by Neurocontrol Corp.
[222547]
A pt was implanted with the freehand system hand grasp neuroprosthesis in 1996. In 2001, the pt reported that the device was not operating properly, as there was no hand stimulation. One day after event date, the external control unit was replaced and some stimulation was restored. However, the stimulation was intermittent and did not produce a grasp. The external system components are believed to be functioning properly, and malfunction of the implantable receiver - stimulator is suspected. Additional testing is being scheduled. Follow up information will be provided when available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2001-00022 |
| MDR Report Key | 340038 |
| Report Source | 00 |
| Date Received | 2001-06-28 |
| Date of Report | 2001-06-28 |
| Date of Event | 2001-05-29 |
| Date Mfgr Received | 2001-05-30 |
| Date Added to Maude | 2001-07-05 |
| 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 |
| 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 | 2001-06-28 |
| Model Number | 1060-1 |
| 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 | 329362 |
| Manufacturer | NEUROCONTROL CORP |
| Manufacturer Address | 8333 ROCKSIDE RD VALLEYVIEW OH 44125 US |
| Baseline Brand Name | FREEHAND SYSTEM |
| Baseline Generic Name | NEUROMUSCULAR STIMULATOR IMPLANT |
| Baseline Model No | 1060-1 |
| 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 | 2001-06-28 |