MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-05-27 for FREEHAND SYSTEM 1060-2 NA manufactured by Neurocontrol Corp..
[19258766]
The patient was implanted with the neurocontrol freehand system in 2000. In april 2003 it was reported that the patient has what appears to be a broken lead on channel 1 of the implantable receiver stimualtor (irs). It appears that the break is a disconnection at the connector site and that the insulation is intact. The patient has been referred for an x-ray of the connector site. The exact location of the break will most likely not be identified until surgery is performed. A follow up report will be submitted after revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2003-00006 |
| MDR Report Key | 462266 |
| Report Source | 04 |
| Date Received | 2003-05-27 |
| Date of Report | 2003-04-28 |
| Date Mfgr Received | 2003-04-28 |
| Device Manufacturer Date | 1998-05-01 |
| Date Added to Maude | 2003-05-30 |
| 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 | KATHIE MIZAK |
| 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 | 2003-05-27 |
| Model Number | 1060-2 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2000-05-01 |
| 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 | 451213 |
| 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 | 2003-05-27 |