MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-13 for NORCURON MICROSTIM PLUS * manufactured by Neuro Technology, Inc.
[3970823]
The patient was being titrated off a paralytic. In an attempt to assess using the nerve stimulator, the caregiver noticed the device's light was not flashing. When the device was opened, a red wire was found to not be connected. A different device was used to finish the process. The wire was connected by biomed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3513843 |
| MDR Report Key | 3513843 |
| Date Received | 2013-11-13 |
| Date of Report | 2013-11-13 |
| Date of Event | 2013-10-06 |
| Report Date | 2013-11-13 |
| Date Reported to FDA | 2013-11-13 |
| Date Reported to Mfgr | 2013-12-11 |
| Date Added to Maude | 2013-12-11 |
| 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 | NORCURON MICROSTIM PLUS |
| Generic Name | STIMULATOR, NERVE, BATTERY-POWERED |
| Product Code | BXN |
| Date Received | 2013-11-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURO TECHNOLOGY, INC |
| Manufacturer Address | 9115 GUILFORD ROAD, SUITE 100 COLUMBIA MD 21046 US 21046 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-13 |