MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-10-18 for FREEHAND SYSTEM 1060-1 NA manufactured by Neurocontrol Corporation.
[255778]
This patient was implanted with the neurocontrol freehand system in 1997. While at this medical center to participate in a clinical study, this device user complained that they could not get their new universal external controller (uec) to function properly. The biomedical engineering staff was able to determine through testing that the external system hardware was functioning properly but that the implantable receiver-stimulator (irs) had malfunctioned. It is likely that the malfunction is due to water vapor generated inside the irs capsule, a problem that was the subject of a previous recall (ref. Neurocontrol product removal report 9028925-11/07/00-003-r). Irs replacement would require surgical intervention, after which a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00012 |
| MDR Report Key | 422672 |
| Report Source | 00 |
| Date Received | 2002-10-18 |
| Date of Report | 2002-10-18 |
| Date of Event | 2002-09-19 |
| Date Mfgr Received | 2002-09-19 |
| Date Added to Maude | 2002-10-22 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | 9028925-11/07/00-003 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEHAND SYSTEM |
| Generic Name | HAND GRASP NEUROPROSTHESIS |
| Product Code | GZC |
| Date Received | 2002-10-18 |
| 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 | 411725 |
| Manufacturer | NEUROCONTROL CORPORATION |
| Manufacturer Address | 8333 ROCKSIDE ROAD VALLEY VIEW 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. Required No Informationntervention | 2002-10-18 |