MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-13 for NEUROSIGN 100 9883-01 manufactured by The Magstim Company Limited.
[187905795]
Magstim's product/clinical specialist contacted the hospital on the issue. Feedback received from the theatre manager suggested that user error caused the issue. It appears that when the device is used when a representative of magstim is present that no issues are reported. Magstim's product/clinical specialist advised the theatre manager that, because of the fact that the machine did not alarm when stimulated, and the post-operative assessment confirmed no injury, the machine probably worked as intended i. E. If it was the nerve that was stimulated, the machine would have alarmed. Although magstim's product/clinical specialist contacted the hospital for advice, the hospital did not want a visit by magstim for training or advice and instead decided to discard the product's use. The magstim company ltd. Is, as per your request, currently in the process of setting up a webtrader account for magstim inc. Usa. During this transition time, please accept this submission as of the magstim company ltd. And magstim inc. Usa both. Exemption number e2018009. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187905796]
Thyroid surgery. Surgeon advised that when stimulating the response was intermittent. Surgeon also advised that he was stimulating the recurrent laryngeal nerve (rln) and there was no response provided by the nerve monitor. Surgeon then alarmed the theatre manager that he had cut the rln and appeared worried about permanent damage. Post-surgery assessment on the patient confirmed that there was no damage caused to the nerve and patient was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011755356-2020-00002 |
| MDR Report Key | 9705519 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-13 |
| Date of Report | 2020-01-17 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-02-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MISS INEKE BOEK |
| Manufacturer Street | SPRING GARDENS |
| Manufacturer City | WHITLAND, CARMARTHENSHIRE SA340HR |
| Manufacturer Country | UK |
| Manufacturer Postal | SA34 0HR |
| Manufacturer G1 | THE MAGSTIM COMPANY LTD. |
| Manufacturer Street | SPRING GARDENS |
| Manufacturer City | WHITLAND, CARMARTHENSHIRE SA340HR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SA34 0HR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROSIGN |
| Generic Name | NEUROSIGN 100 |
| Product Code | ETN |
| Date Received | 2020-02-13 |
| Model Number | 100 |
| Catalog Number | 9883-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE MAGSTIM COMPANY LIMITED |
| Manufacturer Address | SPRING GARDENS WHITLAND, CARMARTHENSHIRE SA340HR UK SA34 0HR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-13 |