MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-12 for NIM? 2.0 MAINFRAME - PULSE 8252201 manufactured by Medtronic Xomed Inc..
[179260477]
Visually, there was no significant damage to the devices that would indicate a cause for the complaint. The interface was plugged into the mainframe and the mainframe power was turned on. The mainframe booted up with no issues or errors. The touchscreen was responsive and accurate. A patient simulator and stimulation probe were plugged into the patient interface. All plugs fit securely in their respective connectors. Channel 1 was green with a resistance of 5. 8kohm on the positive side and 5. 2kohm on the negative side; channel 2 was green with a resistance of 5. 2kohm on the positive side and 5. 9kohm on the negative side. Using 1. 0 ma stimulating current and 150uv threshold; when stimulating, the system consistently returned audio and visual waveform and event tone and stimulating current between 0. 89ma and 0. 90ma. Switching the type of electrode from subdermal to emg tube showed no change to the responses. There was no intermittent behavior while manipulating all connectors / plugs and their strain reliefs. The returned muting cable was plugged into all 4 ports on the back of the mainframe and it did not affect stimulation. Stimulation and responses were checked on all 4 procedures loaded in the system with no issues (parotid, thyroid, mastoid, and acoustic neuroma). There was no malfunction found as it relates to the complaint. With no fault found with the returned device, the information most likely indicates an issue with the set up or the device was used in conflict with the user? S guide. Concomitant medical products: product id: 8252210, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179260478]
A healthcare provider (hcp) reported that the nerve monitoring devices malfunctioned. There was no neurological signal during exploration of the recurrent nerve. There was no known patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00082 |
| MDR Report Key | 9699163 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-08-05 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2006-04-17 |
| Date Added to Maude | 2020-02-12 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIM? 2.0 MAINFRAME - PULSE |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2020-02-12 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 8252201 |
| Catalog Number | 8252201 |
| Lot Number | 44082600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |