MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-02-23 for FREEHAND 1060 * manufactured by Neurocontrol Corp..
[22183049]
Transmit coil to implant coupling is non functional. This makes hand grasp function to be nonfunctional.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2004-00002 |
| MDR Report Key | 512810 |
| Report Source | 05 |
| Date Received | 2004-02-23 |
| Date of Report | 2004-02-19 |
| Date of Event | 2004-01-23 |
| Date Mfgr Received | 2004-01-23 |
| Device Manufacturer Date | 2000-04-01 |
| Date Added to Maude | 2004-02-26 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DARYN KINKOPH |
| Manufacturer Street | 8333 ROCKSIDE RD |
| Manufacturer City | VALLEY VIEW OH 44125 |
| Manufacturer Country | US |
| Manufacturer Postal | 44125 |
| Manufacturer Phone | 2169120101 |
| Manufacturer G1 | * |
| Manufacturer Street | 8333 ROCKSIDE RD |
| Manufacturer City | VALLEY VIEW OH 44125 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44125 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0983-1 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEHAND |
| Generic Name | HAND GRASP NEUROPROSTHESIS |
| Product Code | GZC |
| Date Received | 2004-02-23 |
| Model Number | 1060 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 501817 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE ROAD VALLEYVIEW OH 44125 US |
| Baseline Brand Name | FREEHAND SYSTEM |
| Baseline Generic Name | IMPLANTABLE RECEIVER STIMULATOR |
| Baseline Model No | 1060 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-02-23 |