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

Model Number 2021030

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

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

Event Date 02/20/2020

Event Type  malfunction  

Event Description

During routine servicing of the nvm5 unit, it was found the unit failed simulated stimulation testing; specifically, the unit was not providing appropriate indications of stimulation values.There was no patient involvement.

Manufacturer Narrative

The unit was received for routine servicing.During testing the system was found to fail simulated stimulation testing; specifically, the unit was not providing appropriate indications of stimulation values.The stimulation and acquisition printed circuit boards were replaced to address the issue.The cause of the issue was therefore determined to be the stimulation and acquisition printed circuit boards.There was no patient involvement.Manufacturing review: review of the device history record for the nvm5 pm unit identified no material non-conformances, no manufacturing errors, nor discrepancies that may have caused or contributed to this mode of failure.The system met acceptance criteria upon release.Service history review: review of the service records for the past 24 months for this device identified no similar services in which there was a failure in simulated stimulation testing.Literature 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: NUVASIVE NEXT GENERATION NVM5 SYSTEM
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15271101
• MDR Text Key: 305548693
• Report Number: 2031966-2022-00158
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517089175
• UDI-Public: 887517089175
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162313
• 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: 08/22/2022

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: 2021030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• 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
• Patient Sex: Prefer Not To Disclose