MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-05-16 for NUVASIVE NVM5 SYSTEM NVM5II manufactured by Nuvasive, Inc..
[45276517]
Evaluation of the device has not been possible. No information related to the performance of the device during the surgery has been available for evaluation, although the device's service history does not indicate problems related to failure to detect nerve proximity. No report of malfunction prior to or after the index surgery was reported to nuvasive. No information about the patient's prior nerve conduction capability are known. It is not known if post-placement testing of pedicle screws was performed. Labeling review: 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. Device unavailable.
Patient Sequence No: 1, Text Type: N, H10
[45276518]
Surgery to perform a fusion procedure at l5-s1 spine levels via xlif procedure followed by placement of posterior fixation occurred on (b)(6) 2012. Shortly after surgery, the patient was reported to have had symptoms necessitating surgical intervention. It was reported the neuromonitoring device failed to detect proximity of the pedicle screws to nerves, resulting in nerve injury. Revision surgery occurred on (b)(6) /2012 in which repositioning of the screws was performed. The patient reported that a permanent "foot drop-like condition and chronic pain" resulted from the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2016-00039 |
| MDR Report Key | 5658465 |
| Report Source | OTHER |
| Date Received | 2016-05-16 |
| Date Mfgr Received | 2016-02-20 |
| Date Added to Maude | 2016-05-16 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PAUL HOLBROOK |
| Manufacturer Street | 7475 LUSK BOULEVARD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8583205285 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUVASIVE NVM5 SYSTEM |
| Generic Name | NEUROSURGICAL NERVE LOCATOR |
| Product Code | PDQ |
| Date Received | 2016-05-16 |
| Model Number | NVM5II |
| Catalog Number | NVM5II |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Deathisabilit | 2016-05-16 |