MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-09-20 for FREEHAND SYSTEM UNK NA manufactured by Neurocontrol Corp..
[250093]
In 2002, a clinician submitted a request for replacement freehand system components. However, the reason for this request was unclear and did not resasonably suggest that an mdr reportable event had occurred. Clarification was requested and, on 08/21/2002, it was determined that this pt may have a freehand implanted epimysial electrode that has malfunctioned. The clinician reported that this pt routinely places their forearm on the edge of a table to write, which may have cut the insulation of this electrode lead. Testing is required to determine the actual malfunction. A revision surgery to replace the electrode will be required to restore device function. The identity of this pt and all related info (date of birth, sex, date of implant, specific device identification, etc). Are unknown at this time, but a follow-up report will be sumbitted when this info is available. Also a follow-up report will be submitted following a revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00011 |
| MDR Report Key | 417630 |
| Report Source | 05 |
| Date Received | 2002-09-20 |
| Date of Report | 2002-08-21 |
| Date of Event | 2002-06-28 |
| Date Mfgr Received | 2002-08-21 |
| Date Added to Maude | 2002-09-24 |
| 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 | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEHAND SYSTEM |
| Generic Name | HAND GRASP NEUROPROSTHESIS |
| Product Code | GZC |
| Date Received | 2002-09-20 |
| Model Number | UNK |
| 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 | 406662 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE RD. VALLEY VIEW OH 44125 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-09-20 |