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 2016-04-11 for NVM5 SYSTEM 2021000006 manufactured by Nuvasive, Inc..
[42336764]
The device was evaluated and passed functional testing. It is not known if the patient had a history of chronically compressed nerves. It is not known if the surgeon allowed sufficient time for the device's positioning system to detect nerve tissue properly. The root cause of this reported event has not been determined. Labeling review: "precaution: the nvm5? System is to be used only as an adjunct to medical judgment and appropriate surgical practices. Dilator insertion and advancement should be conducted only after careful analysis of radiographic images of the operative target area. While a positive emg detection by the nvm5 system can be associated with a high level of certainty that a nerve is in close proximity to the dilator tip, the absence of such an emg detection cannot be construed as a certain indication that no nerves are close to the dilator tip. Do not advance dilator probes until all available data have been considered. " "precaution: do not advance the dilator faster than the rate of update of detection data. " "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
[42336765]
On (b)(6) 2016, a (b)(6) female underwent a lateral interbody fusion procedure at l2-l5. After insertion of a retractor at l4/5, the m5 display was unstable so the surgeon passed the dilator in and out multiple times in order to avoid nerve contact. The surgery completed with total hemorrhage of 300cc and the patient received a blood transfusion. Posterior fixation was planned on (b)(6) 2016 but was postponed because the patient did not feel well and was unable to walk with numbness of the right thigh due to swelling and hematoma of the psoas major.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2016-00027 |
| MDR Report Key | 5567785 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-04-11 |
| Date of Report | 2016-04-11 |
| Date of Event | 2016-03-09 |
| Date Added to Maude | 2016-04-11 |
| 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 | MS. STACY GREGORY |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8587360313 |
| 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 | 2016-04-11 |
| Returned To Mfg | 2016-03-31 |
| Model Number | 2021000006 |
| Lot Number | SM20095 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-04-11 |