MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2002-12-05 for NEUROCONTROL FREEHAND SYSTEM 1060-1 NA manufactured by Neurocontrol Corp..
[251109]
This pt was implanted with the freehand system in 1996. In approx 4/1997, the freehand implantable receiver-stimulator (irs) became esd converted, but the system was successfully reprogrammed and was then fully functional. The pt has since used the device on a very limited basis due to unrelated medical issues. In 2001 the pt reported receiving uncomfortable "shocks" at the time the device is turned on, which has happened with sufficient frequency to discourage the pt's use of the device. The problem could not be confirmed through testing that was performed at that time. However, based upon the results of recent pt testing, the problem has been confirmed and it is now believed that the freehand irs has 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 9028925-11/7/00-003-r). Irs replacement will require surgical intervention, after which a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00015 |
| MDR Report Key | 430872 |
| Report Source | 00,01,06 |
| Date Received | 2002-12-05 |
| Date of Report | 2002-11-05 |
| Date of Event | 2002-03-15 |
| Date Mfgr Received | 2002-11-05 |
| Device Manufacturer Date | 1996-08-01 |
| Date Added to Maude | 2002-12-05 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROCONTROL FREEHAND SYSTEM |
| Generic Name | HAND GRASP NEUROPROSTHESIS |
| Product Code | GZC |
| Date Received | 2002-12-05 |
| 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 | 419857 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE RD 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 | 2002-12-05 |