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

Model Number NVM5MULTICART

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

This event is being reported as part of a retrospective review of servicing events.The device was received for servicing.During testing, the system 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 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 past 24 months 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 (b)(4) 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 (b)(4) 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 (b)(4) 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.".

Event 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.

• Brand Name: NVM5 W/SSEP, BENDINI, EMG, MEP ON A CART
• Type of Device: 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: 15317124
• MDR Text Key: 305532014
• Report Number: 2031966-2022-00165
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517521064
• UDI-Public: 887517521064
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Model Number: NVM5MULTICART
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1