MAUDE Adverse Event Report: NUVASIVE NUVASIVE NVM5 SYSTEM; NEUROSURGICAL NERVE LOCATOR

Model Number 2023000

Device Problems No Audible Alarm (1019); False Negative Result (1225)

Patient Problem Nerve Damage (1979)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

The hospital owned device was not returned to nuvasive for evaluation and the complaint could not be confirmed.Reportedly the patient was being monitored with mep alert threshold but not visually watched and it is unknown if the audible alarm feature was activated or not.Review of the provided case report identified the device was in mep threshold mode not mep alarm threshold mode and time between runs varied up to over an hour and a half between testing intervals.Case review also clearly captured two bilateral completed mep potential signal loss events at l4 during the case that when triggered provide visual and audible alerts if the audible alert feature is activated.The root cause could not be definitively determined as the device was not returned for functionality testing and though the provided case report confirmed the monitor did record several episodes of mep potential loss as designed the visual prompts were reportedly not be watched and operator configured audible alert settings can't be confirmed.Note the operator selected extended length of time between testing intervals and the reported no active visual monitoring appear to be the cause or major contributor to the delayed treatment and acknowledgement of experienced and recorded deficit.No additional investigation can be completed.Labeling review: "potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity.Rarely, some complications may be fatal." "warnings, cautions and precautions: read all instructions and understand all warnings and cautions before using the nvm5 system and accessories.Failure to do so may lead to serious medical consequences.Refer to the instructions for use accompanying other nuvasive devices before use with the nvm5 system to confirm proper use of these devices." "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." "mep stimulation may introduce additional hazards to the patient through use.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." "if system data acquisition seems inaccurate or if the software application does not initiate or malfunctions during use, and recommended steps to restore the system are not successful, abort use of the system." "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 proper placement of instruments, the procedure should be suspended." "using the provided electrode placement instructions, extreme care should be taken to confirm that the recording electrodes have been placed on the correct muscle groups, and on the correct side of the patient, before plugging the emg harness into the patient module.Failure to follow these instructions may result in the display of inadequate information necessary for data interpretation." "remain alert for audible indications of emg-like activity as an indicator of nerve trauma.Lack of audible feedback may indicate speaker system malfunction." "audible alert notification of spontaneous emg events will not be generated when the nvm5 system is used with the ¿mute¿ setting activated.To receive all possible audible alerts when using the nvm5 system, confirm that the ¿mute¿ setting is not activated." "pre-operative warnings: the methods of use of instruments are to be determined by the user¿s experience and training in surgical procedures.The instruments should be carefully examined prior to use for functionality, excessive wear, or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury.Inspect all components for damage before use.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "method of use: please refer to the nvm5 system product reference manual (doc #9400247) for use of the entire system (software, camera, and accessories).Refer to the instructions for use accompanying other nuvasive devices for proper use of these device." (b)(4).

Event Description

On (b)(6) 2022 a patient underwent a transforaminal lumbar interbody fusion procedure from l2 to illiac where neuro monitoring was utilized.There were no issues with twitch testing or mep threshold waveform during the procedure but after extubating the patient a wake test revealed poor movement of the right quadriceps muscle.Intraoperatively, the right l4 route was on but was not being visually monitored and was reportedly in mep alert threshold mode.It was decided to decompress l4 again, and the movement of the quadricep improved slightly after decompression.The surgeon reported the l3 route was fine, so he believed the reaction of the quadricep occurred intraoperatively as possibly the result of a false negative.

• Brand Name: NUVASIVE NVM5 SYSTEM
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 15955029
• MDR Text Key: 305241548
• Report Number: 2031966-2022-00278
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517079855
• UDI-Public: 887517079855
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2023000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female