MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-12 for * NEUROVISION manufactured by Nuvasive, Inc..
[515873]
The patient had a nerve monitoring system used during a hemilaminectomy and discectomy. The patient complained of pain post-operatively and burn wounds discovered on legs where the electrodes were placed. Patient has blistering and low-grade burns, 3 burns to each leg and one on her abdomen. The patient is being seen by plastic surgery and is getting conservative treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 747198 |
| MDR Report Key | 747198 |
| Date Received | 2006-07-12 |
| Date of Report | 2006-07-12 |
| Date of Event | 2006-06-23 |
| Report Date | 2006-07-12 |
| Date Reported to FDA | 2006-07-12 |
| Date Added to Maude | 2006-08-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | EMG, MONITOR, STIMULATOR |
| Product Code | GZI |
| Date Received | 2006-07-12 |
| Returned To Mfg | 2006-06-23 |
| Model Number | NEUROVISION |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 734974 |
| Manufacturer | NUVASIVE, INC. |
| Manufacturer Address | 10065 OLD GROVE ROAD SAN DIEGO CA 92131 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-12 |