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 2017-03-20 for NVM5 SYSTEM 2021000006 manufactured by Nuvasive, Inc.
[70367251]
Intravenous anesthesia was not used and mep waveform was not detected from the beginning of the first case. The system is designed to identify mechanically induced myotome contractions during operation. In both cases, it was reported a noise was detected during free run emg and the surgeon proceeded with the case without determining the cause. The system did not return for evaluation. The root cause is unknown, but may be related to a relevant comorbidity known to require modified perioperative medication management and also known to result in abandonment of neuromonitoring. No further investigation can be conducted at this time. Labeling review: "free run emg - the free run emg function identifies spontaneous emg activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions. " warning: chronically compressed nerves, or severely compressed nerves in an acute setting, are known to be less sensitive to depolarization currents (i. E. , have significantly higher depolarization current values). They are also less likely to demonstrate significant changes in their threshold depolarization current values immediately following nerve decompression. Under such circumstances, exercise caution in interpreting displayed data.
Patient Sequence No: 1, Text Type: N, H10
[70367252]
On (b)(6) 2017, a (b)(6) female patient underwent shortening osteotomy of t12 using another manufacturer's interbody device. Neuromonitoring was used during the procedure which produced a undetected noise on the left anterior muscle after the rod insertion. The surgery proceeded without determining the nature of the noise. Patient recovery from anesthesia was long after surgery. The following morning, patient experienced paralysis of the lower extremities and a revision surgery was performed to provide additional decompression. Neuromonitoring was used and a noise was detected on the left gastrocnemius medialis. The surgery continued without determining the nature of the noise. Paralysis of the lower extremities did not improve after surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2017-00020 |
| MDR Report Key | 6417726 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-20 |
| Date of Report | 2017-03-20 |
| Date of Event | 2017-02-02 |
| Date Mfgr Received | 2017-02-21 |
| Date Added to Maude | 2017-03-20 |
| 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 | KIM MCCALEB |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8589091980 |
| Manufacturer G1 | NUVASIVE, INC |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NVM5 SYSTEM |
| Generic Name | NEUROSURGICAL NERVE LOCATOR |
| Product Code | PDQ |
| Date Received | 2017-03-20 |
| Model Number | 2021000006 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INC |
| Manufacturer Address | 7475 LUSK BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-20 |