MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-02-13 for FREEHAND SYSTEM 1060-2 * manufactured by Neurocontrol Corp..
[307159]
Patient was implanted with freehand irs in 2001 as part of a lower extremity study not sponsored by the manufacturer. The freehand implantable intramuscular (im) electrode to channel 1 originally gave poor response for approx. 1 1/2 years, then gave no response at all. New im electrode was implanted during a revision surgery in 2003 and did elicit a good muscle response from all sources except channel 1 of the irs during testing. Replacement im electrode was left connected to channel 1 even though there was no apparent output; the irs has programmable current on the other 7 channels and appears to operate correctly. It is suspected that the im connector may have malfunctioned. Follow up report will be submitted once further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2003-00001 |
| MDR Report Key | 442470 |
| Report Source | 06 |
| Date Received | 2003-02-13 |
| Date of Report | 2003-01-15 |
| Date Mfgr Received | 2003-01-15 |
| Device Manufacturer Date | 1997-09-01 |
| Date Added to Maude | 2003-02-14 |
| 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 | FREEHAND SYSTEM |
| Generic Name | HAND GRASP NEUROPROSTHESIS |
| Product Code | GZC |
| Date Received | 2003-02-13 |
| Model Number | 1060-2 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 2002-09-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 431452 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE RD. VALLEYVIEW OH 44125 US |
| Baseline Brand Name | FREEHHAND SYSTEM |
| Baseline Generic Name | NEUROMUSCULAR STIMULATOR IMPLANT |
| Baseline Model No | 1060-2 |
| 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 | 2003-02-13 |