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

Model Number 2021001

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

Patient Problem Paralysis (1997)

Event Date 07/28/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is currently in progress.When additional information is received a supplemental medwatch will be completed.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and / or deformity." "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 Description

It was reported that a neuromonitoring system used during a scoliosis correction case from t2 to t11 did not display neurological activity indicating any issue commensurate with the post-operative complete motor deficit sustained by the patient.It was also reported that during the case emg interference was seen as well as unilateral delayed responses on a lower limb when conducting motor evoke potential (mep) stimulation.Additionally, following the case, mri imaging revealed that a pedicle screw had been placed in the spinal canal, for which a revision procedure was conducted on (b)(6) 2023 to replace the malplaced screw.Since the revision it was reported that the patient had started showing signs of motor recovery.

Event Description

See h10 for updated information.

Manufacturer Narrative

The device was returned for evaluation.Testing was unable to identify any issue related to the reported event; the device passed all relevant testing, indicating no stimulation or recording issues present in the device.Additionally, a review of service records for this system from the past 12 months identified no previous services related to the reported event, indicating no recurring issue is present.Based on the information obtained, the root cause of the reported event is unknown, but may have been the result of patient set-up or inaccurate baseline reading establishment.System testing indicated that the device was functioning as intended; however, it is unknown what environmental factors may have contributed to the event during the case.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity." "warnings, cautions and precautions read all instructions and understand all warnings and cautions before using the nvm5 system and accessories.Failure to do so may lead to serious medical consequences.Refer to the instructions for use accompanying other nuvasive devices before use with the nvm5 system to confirm proper use of these devices." "chronically compressed nerves, or severely compressed nerves in an acute setting, are known to be less sensitive to depolarization currents (i.E., have significantly higher depolarization current values).They are also less likely to demonstrate significant changes in their threshold depolarization current values immediately following nerve decompression.Under such circumstances, exercise caution in interpreting displayed data." 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." "using the provided electrode placement instructions, extreme care should be taken to confirm that the recording electrodes have been placed on the correct muscle groups, and on the correct side of the patient, before plugging the emg harness into the patient module.Failure to follow these instructions may result in the display of inadequate information necessary for data interpretation." "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
• Type of Device: 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: 17647135
• MDR Text Key: 322242780
• Report Number: 2031966-2023-00180
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517168610
• UDI-Public: 887517168610
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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
• Device Operator: Health Professional
• Device Model Number: 2021001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2011
• 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
• Treatment: NVM5 PATIENT MODULE.
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 30 KG