MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2002-06-04 for NEUROCONTROL FREEHAND SYSTEM 1060-1 NA manufactured by Neurocontrol Corp..
[275957]
This patient was implanted with the freehand system in 2001. The patient reportedly achieved good hand grasp results until undergoing a posterior deltoid-to-triceps tendon transfer surgery performed to improve grasp results approximately one month following the initial device implantation surgery. At that time it is believed that the implantable receiver-stimulator (irs) underwent an electrostatic discharge (esd) conversion, which was reportedly caused by the use of a monopolar electrocautery device during the surgery (specifically contraindicated in the device labeling). Freehand irs esd conversion was the subject of a previous neurocontrol product removal (ref. H. 10. ). The effects of the irs eds conversion were addressed by the patient grasp parameter reprogramming of the external control unit (ecu), following which additional problems were identified. It was found that no stimulation of any muscle is observed from irs channel 1 (abpb), and that irs channel 5 (fds) causes muscle contraction of both abpb and fds and that no adjustment of stimulation parameters allows the separation of these muscle responses. It is suspected that this co-stimulation is due to the placement of the fds electrode too close to the median nerve. Both problems will require a revision surgery to correct. A follow-up report will be provided when additional information is available following the revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00007 |
| MDR Report Key | 398261 |
| Report Source | 01,05,06 |
| Date Received | 2002-06-04 |
| Date of Report | 2002-05-06 |
| Date of Event | 2001-12-01 |
| Date Mfgr Received | 2002-05-06 |
| Device Manufacturer Date | 2000-02-01 |
| Date Added to Maude | 2002-06-10 |
| 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 |
| Removal Correction Number | 9028925-06/10/98-001 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROCONTROL FREEHAND SYSTEM |
| Generic Name | HAND GRASP NEUROPROSTHESIS |
| Product Code | GZC |
| Date Received | 2002-06-04 |
| 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 | 387309 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE RD. VALLEY VIEW OH 441256104 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 | 2002-06-04 |