MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE NEXT GENERATION NVM5 SYSTEM; NEUROSURGICAL NERVE LOCATOR

Model Number NVM5MULTI994

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535); Computer Operating System Problem (2898)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Testing of the device was unable to replicate any issue related to the reported event.No problem was found with the system in relation to the measurement of neuromonitoring signals, stimulation, noise or interference, or any system function that would impact the operation of the device.Based on the information obtained the root cause of the reported event was unable to be determined conclusively, but may have been related to patient set-up or environmental conditions.Labeling review: warnings, cautions and precautions: 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." "pre-operative warnings: the methods of use of instruments are to be determined by the user¿s experience and training in surgical procedures.".

Event Description

It was reported that during neuromonitoring via electromyography, incorrect values related to nerve proximity were obtained while using a probe.Specifically, while using the probe, values indicating distant nerve proximity were obtained despite the nerve plexus being directly visible in the surgical field.It was also reported the neuromonitoring unit experienced channel noise/interference as well as operating system errors.Attempts to resolve these issues via powering the device on and off and switching electrical outlets were unsuccessful; therefore, the surgery was abandoned.There was no report of patient harm or further impact as a result of this event.

• Brand Name: NUVASIVE NEXT GENERATION NVM5 SYSTEM
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 19084365
• MDR Text Key: 340579684
• Report Number: 2031966-2024-00103
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517668257
• UDI-Public: 887517668257
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K162313
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NVM5MULTI994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• 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
• Treatment: NEUROMONITORING PROBE.
• Patient Sex: Prefer Not To Disclose