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

Model Number	2021000
Medical Device Problem Codes	Communication or Transmission Problem (2896); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned to nuvasive for evaluation.Additionally, a detailed description of the system issue was not provided.The complaint was unable to be confirmed with the information provided.Based on the information obtained, the root cause of the reported issue was unable to be determined.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." h3 other text : not returned to manufacturer.
Event or Problem Description
It was reported that a patient underwent a spinal surgery on l2 to l5 for which the use of neuromonitoring was planned; however, the system was not working and the surgeon opted to continue the case without neuromonitoring.The patient sustained a nerve injury during the procedure.
Event or Problem Description
Updated information in h10.
Additional Manufacturer Narrative
The device was returned for evaluation.Device testing found the the patient module (pm) would not connect to the control unit (cu) but would connect to a known good pm unit.The device was sent to repair where the pm di circuit board was replaced due to the connection issue.Review of the reported information received identified that even through neuromonitoring was not available, the surgeon opted to continue with the case.No other information was provided regarding the patient injury.Based on the information obtained the cause of the reported system operational issue can be attributed to a failure in the pm di circuit board, which caused connection issues with the cu, impeding device operation.However, the cause of the patient impact can be attributed to the surgeon proceeding with the case without the use of the nvm5 system for neuromonitoring.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: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 17603037
• Report Number: 2031966-2023-00176
• Device Sequence Number: 6125602
• Product Code: PDQ
• UDI-Device Identifier: 00887517168603
• UDI-Public: 887517168603
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K162313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2021000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White