MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-07-03 for NEUROSIGN CONCENTRIC PROBE 3600-00-TE manufactured by The Magstim Company Limited.
[112998732]
Please note that this report relates to report number 8021774-2018-00001. Magstim is currently awaiting the neurosign 100 device back from the customer for investigation of the device. Magstim could not investigate the functionality of the probe that was used during the surgery as this was discarded. Nevertheless, the hospital personnel were able to recover the packaging and the batch number could be confirmed. A batch record review was performed for this lot number, which confirmed that there were no anomalies for this batch. In addition to this, two retained samples were tested of this batch (electrical performance), which showed that these probes were functioning as required. Moreover, the tip was inspected under the microscope (50x magnification) and both tips did not show any deviations or abnormalities. All probes are checked for functionality before leaving the manufacturing site and will not be released if not functioning. Although the outcome of the neurosign 100 investigation is not yet available, an analysis was made by our neurosign business manager on the event. He advised that the used probe (concentric probe) would not be suitable for middle ear procedures, as the probe does not stimulate through bone. Different probes are available for this part of the ear. This information is available in brochure neurosign stimulating probes? 2017 - marketing document number: (b)(4) (available upon request). Without full investigation results available at this point, a final root cause cannot yet be determined. Magstim will inform you as soon as the results of the device investigation of the neurosign 100 are available.
Patient Sequence No: 1, Text Type: N, H10
[112998733]
Patient (b)(6) (f, (b)(6)), underwent a stapedectomy surgery indicated for otosclerosis on the (b)(6) 2018. The patient had an aberrant facial nerve. During the surgery a neurosign 100 and a neurosign concentric probe were used for nerve monitoring. As reported by the customer, the device did not identify direct stimulation or manipulation of the nerve. The patient was reviewed in the recovery unit (pacu) after the surgery, where the surgeon noticed facial asymmetry, or also reported as partial facial palsy, which could potentially be a permanent injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021774-2018-00002 |
| MDR Report Key | 7657793 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-03 |
| Date of Report | 2018-06-25 |
| Date of Event | 2018-06-19 |
| Report Date | 2018-06-25 |
| Date Reported to Mfgr | 2018-06-25 |
| Date Mfgr Received | 2018-06-25 |
| Device Manufacturer Date | 2015-08-01 |
| Date Added to Maude | 2018-07-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MISS INEKE BOEK |
| Manufacturer Street | WHITLAND INDUSTRIAL ESTATE SPRING GARDENS |
| Manufacturer City | WHITLAND, CARMARTHENSHIRE SA340HR |
| Manufacturer Country | UK |
| Manufacturer Postal | SA34 0HR |
| Manufacturer G1 | THE MAGSTIM COMPANY LIMITED |
| Manufacturer Street | WHITLAND INDUSTRIAL ESTATE SPRING GARDENS |
| Manufacturer City | WHITLAND, CARMARTHENSHIRE SA340HR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SA34 0HR |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROSIGN CONCENTRIC PROBE |
| Generic Name | NEUROSIGN CONCENTRIC PROBE |
| Product Code | GXZ |
| Date Received | 2018-07-03 |
| Model Number | 3600-00-TE |
| Lot Number | 030910 |
| Device Expiration Date | 2018-08-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 35 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE MAGSTIM COMPANY LIMITED |
| Manufacturer Address | WHITLAND INDUSTRIAL ESTATE SPRING GARDENS WHITLAND, CARMARTHENSHIRE SA340HR UK SA34 0HR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-07-03 |