MAUDE Adverse Event Report: NUVASIVE, INC. NVM5 W/EMG, MEP, SSEP, BENDINI & NUVAMAP; NEUROSURGICAL NERVE LOCATOR

Model Number	NVM5MULTI
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During servicing of the nvm5 unit, it was found the unit failed simulated stimulation testing; specifically, the unit was not providing appropriate responses to returned stimulation values.There was no patient involvement.
Additional Manufacturer Narrative
This event is being reported as part of a retrospective review of servicing events.During servicing of the nvm5 unit, it was found the unit failed simulated stimulation testing; specifically, the unit was not providing appropriate responses to returned stimulation values.The stimulation board was found faulty and the patient module was replaced to address the issue.The cause of the issue can therefore be attributed to the stimulation board.Service history review: review of the service records for the three previous service events for this device identified no similar service events in which the system was found to fail simulated stimulation testing or had the stimulation board replaced.Labeling review: "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 proper placement of instruments, the procedure should be suspended.The nvm5 system is to be used only as an adjunct to medical judgment and appropriate surgical practices.Dilator insertion and advancement should be conducted only after careful analysis of radiographic images of the operative target area.While a positive emg detection by the nvm5 system can be associated with a high level of certainty that a nerve is in close proximity to the dilator tip, the absence of such an emg detection cannot be construed as a certain indication that no nerves are close to the dilator tip.Do not advance dilator probes until all available data have been considered.".

• Brand Name: NVM5 W/EMG, MEP, SSEP, BENDINI & NUVAMAP
• Common Device Name: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 15317126
• Report Number: 2031966-2022-00164
• Device Sequence Number: 17522313
• Product Code: PDQ
• UDI-Device Identifier: 00887517168603
• UDI-Public: 887517168603
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K143579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2022

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: Other
• Device Model Number: NVM5MULTI
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 08/29/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown