MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-21 for CASCADE EMG/EP/EEG IOM manufactured by Cadwell Industries, Inc..
[55233104]
Patient Sequence No: 1, Text Type: N, H10
[55233105]
During spinal surgery, the neurostimulator rep noted changed on the monitor and evaluated the electrode pins on the patient. The rep noted burns at the electrode pin sites.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5966099 |
| MDR Report Key | 5966099 |
| Date Received | 2016-09-21 |
| Date of Report | 2016-09-01 |
| Date of Event | 2016-05-18 |
| Report Date | 2016-09-01 |
| Date Reported to FDA | 2016-09-01 |
| Date Reported to Mfgr | 2016-09-01 |
| Date Added to Maude | 2016-09-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASCADE EMG/EP/EEG IOM |
| Generic Name | STIMULATOR, PHOTIC, EVOKED RESPONSE |
| Product Code | GWE |
| Date Received | 2016-09-21 |
| Returned To Mfg | 2016-06-23 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CADWELL INDUSTRIES, INC. |
| Manufacturer Address | 909 NORTH KELLOGG STREET KENNEWICK WA 99336 US 99336 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-21 |