MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2006-09-29 for FREEHAND 1060-1 NA manufactured by Neurocontrol Corp..
[639833]
The implantable stimulator malfunctions. Five channels stopped and 3 channels generated erratic stimulation. No injury to the pt has been reported. The stimulator is not a life supporting device. The device controls hand grasp function of spinal-cord injured pts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2006-00001 |
| MDR Report Key | 858805 |
| Report Source | 01,05 |
| Date Received | 2006-09-29 |
| Date of Report | 2006-09-29 |
| Date Mfgr Received | 2006-09-08 |
| Device Manufacturer Date | 1998-05-01 |
| Date Added to Maude | 2007-06-04 |
| 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 | SOHEYL POURMEHDI, PH.D. DIR |
| Manufacturer Street | 38683 TAYLOR PKWY |
| Manufacturer City | NORTH RIDGEVILLE OH 44039 |
| Manufacturer Country | US |
| Manufacturer Postal | 44039 |
| Manufacturer Phone | 4403263809 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEHAND |
| Generic Name | IMPLANTABLE NEUROPROSTHESIS FOR HAND GRASP |
| Product Code | GZC |
| Date Received | 2006-09-29 |
| 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 | 842480 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 38683 TAYLOR PARKWAY NORTH RIDGEVILLE OH 44039 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-29 |