MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-02-08 for NVM5 SYSTEM NVM5MULTI manufactured by Nuvasive, Inc..
[66860595]
The patient reportedly has received an unspecified additional surgery to address the injury. No further information has become available to determine device identification and/or if the device malfunctioned. No information is known about possible pre-existing conditions, medication administration or anatomical characteristics which may have influenced the device's performance. Labeling review: contraindication: neuromuscular block or paralytics should not be in effect during the use of nvm5 emg as they might interfere with the electromyography readings. Contraindication: do not attempt to use this device when using paralyzing agents on the patient, as nerve surveillance may be compromised. 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. Warning: a red channel may indicate a disconnected or separated electrode or poor electrode impedance. If a failed channel or channel that has been disabled is accepted, responses from this channel will not be detected during stimulation. This could lead to a false-negative result if the myotome is innervated by the spinal level under test. Free run events on this channel will not be detected. Precaution: while the nvm5 system is designed to assist in the electromyographic location of spinal nerves in proximity to the surgical site, it is not intended to take the place of thorough knowledge of spinal anatomy and appropriate surgical technique, nor should the information provided by the system be construed as definitive indicators of nerve location. Such factors as the distance from the nerve, the position and placement of electrodes, individual muscle and/or nerve responses, the proximity and strength of sources of electrical interference, and other patient and environmental factors, may influence the operation. If, in the judgment of the clinician, this resistance is sufficient to preclude safe placement of instruments, the procedure should be suspended. System was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[66860596]
On (b)(6) 2014 a male patient reportedly underwent a lateral procedure at l4-l5. During the procedure, the connection between the implant and the inserter reportedly broke requiring removal and replacement of the implant. The report further indicates the belief that intra-operative neuromonitoring failed to detect nerve presence (undetected false negative) and this resulted in injury to nerves manifesting itself as burning sensations, pain in the patient's left leg and psoas muscle in addition to ambulation difficulty and generalized lower extremity weakness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2017-00005 |
| MDR Report Key | 6313183 |
| Report Source | OTHER |
| Date Received | 2017-02-08 |
| Date of Report | 2017-02-07 |
| Date of Event | 2014-08-04 |
| Date Mfgr Received | 2017-01-11 |
| Date Added to Maude | 2017-02-08 |
| 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 | NVM5 SYSTEM |
| Generic Name | NEUROSURGICAL NERVE LOCATOR |
| Product Code | PDQ |
| Date Received | 2017-02-08 |
| Model Number | NVM5MULTI |
| Operator | PHYSICIAN |
| Device Availability | * |
| 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 | 2017-02-08 |