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

Model Number	2023000
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a facility using neuromonitoring during a procedure was unable to elicit adequate nerve response signals during equipment set-up from a patient following a successful twitch test.The issue was unable to be resolved and the procedure was stopped and rescheduled for on (b)(6) 2024.
Additional Manufacturer Narrative
No device was returned for evaluation.Photographs of the system display during the set up issue were provided to confirm the complaint.Information on initial troubleshooting was provided by the initial reporter was provided; however, no potential causes could be identified based on the information available.Based on the information obtained the root cause of the reported event was unable to be determined conclusively, but may have been related to possible system issues or patient set-up and 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.".

• Brand Name: NUVASIVE NEXT GENERATION NVM5 SYSTEM
• Common Device Name: 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: macy stout ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 20466992
• Report Number: 2031966-2024-00264
• Device Sequence Number: 7368960
• Product Code: PDQ
• UDI-Device Identifier: 00887517957368
• UDI-Public: 887517957368
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K162313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown