MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-24 for NEUROSIGN 100 * manufactured by The Magstim Company Ltd.
[19732885]
Pt was having a tympanomastoidectomy and neurosign facial nerve monitor was placed on left face prior to draping. Volume alarm and bar were set. During case, no alarm nor change in bar were noted. Case ended uneventfully, and pt went to pacu. Dr let me know that there was issues with the facial nerve and he began treatment. I removed the neurosign from service and contacted biomed to come evaluate it. Pmm's last performed approximately 2 weeks prior to event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3549820 |
| MDR Report Key | 3549820 |
| Date Received | 2013-12-24 |
| Date of Report | 2013-12-24 |
| Date of Event | 2013-12-05 |
| Report Date | 2013-12-24 |
| Date Reported to FDA | 2013-12-24 |
| Date Reported to Mfgr | 2014-01-03 |
| Date Added to Maude | 2014-01-03 |
| 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 | NEUROSIGN 100 |
| Generic Name | STIMULATOR, NERVE |
| Product Code | JXE |
| Date Received | 2013-12-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE MAGSTIM COMPANY LTD |
| Manufacturer Address | 304 CAMBRIDGE ROAD SUITE 310 WOBURN MA 01801 US 01801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-24 |