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

Model Number 2021000

Device Problem Electromagnetic Interference (1194)

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

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Additionally, no photographs of the system message were provided to confirm the complaint.Based on the limited information obtained the root cause of the reported issue could not be determined; however, electocautery interference is most likely caused by electrical noise from equipment in the operating room or operating room electrical wiring.No additional investigation can be completed.Labeling review: "contraindications.Do not use cutaneous electrodes for stimulation (stimulation electrodes) if the patient has a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device.Such use could cause electric shock, burns, electrical interference." "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.Poor electrode impedance may create susceptibility to electrical interference, which can adversely affect system performance.".

Event Description

On (b)(6) 2022 during an extreme lateral interbody fusion an nvm5 system displayed a notification that indicated there was "electocautery interference" and stimulation could not be performed.Troubleshooting was performed by switching off the bed and electocautery unit, ensuring the x-ray was at a distance, and replacing the ground electrodes; however, the issue could not be resolved.The surgeon altered the surgical plan and proceeded with a posterior transforaminal lumbar interbody fusion.

Manufacturer Narrative

The device was returned to nuvasive and the complaint was not confirmed however, out of date software was identified though unrelated to the reported event.During examination the electrocautery interference could not be identified or recreated, performance verification testing was successfully completed and repeated where the device was determined to be functioning within design specifications.Additionally all routine service activities were performed as required.The root cause could not be determined though poor patient prep, wiring harness integrity, (not returned for evaluation) facility wiring as well as environmental interference are possible cause or contributors.No additional investigation can be completed.Labeling review: ".Contraindications: do not use the nvm5 system in conjunction with high frequency electromagnetic diathermy devices.Failure to do so may result in patient burns at the electrode sites." ".Minimize coupling with electrosurgical equipment when setting up the nvm5 system.Some actions that may help reduce electrical coupling include: locate the electrosurgical patient return pad as close to the surgical site as practical; route the monopolar and bipolar electrosurgical wiring together and away from any other patient connected leads and electrodes; minimize the activation of electrosurgical instruments while they are not in patient contact; plug the electrosurgical generator equipment into a separate power outlet from any other patient-connected electrical device; and use the lowest electrosurgical power setting that achieves the surgical requirement." ".Precaution: the nvm5 system is not protected against the effects of defibrillation.Do not use in conjunction with a defibrillator.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." ".Poor electrode impedance may create susceptibility to electrical interference, which can adversely affect system performance." ".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." ".Only use electrodes supplied with the nvm5 system.Use of other electrodes may adversely affect results.Do not place stimulation electrodes over the patient¿s neck because this could cause severe muscle spasms resulting in closure of the patient¿s airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.Do not place stimulation electrodes across the patient¿s chest because the introduction of electrical current into the chest may cause rhythm disturbances to the patient¿s heart, which could be lethal.Do not place stimulation electrodes over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.G., phlebitis, thrombophlebitis, varicose veins); and do not place stimulation electrodes over, or in proximity to, cancerous lesions.Electrodes should be applied only to normal, intact, clean, healthy skin.The size, shape, and type of electrodes may affect the safety and effectiveness of electrical stimulation and recording.Using stimulation electrodes that are too small or incorrectly applied could result in discomfort or skin burns.Use caution if electrodes are applied over areas of skin that lack normal sensation." ".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." ".To optimize accuracy of emg recording, the emg common electrode should be located between the site of stimulation and the recording electrodes (e.G., on the flank).The nvm5 system contains sensitive electronic components which may be damaged by electrostatic discharge (esd).Normal precautions should be taken to avoid causing esd impulses to occur directly on the emg input electrodes.For example, it is recommended that before touching the emg electrodes, the operator should touch the barrel of the main cable connector between the control unit and the patient module to reduce any accumulated charge on the operator." ".A thorough cleaning and preparation of the dermal surface prior to placement of recording electrodes is required for proper adherence and sensitivity of the electrodes.It is recommended to apply sufficient skin preparation to achieve acceptable electrode impedance.Caution should be exercised during skin preparation and electrode removal.Excessive preparation and/or sudden removal may lead to skin reaction and abrasion." ".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." ".The use of electrosurgical equipment near the nvm5 system¿s emg electrodes may damage the patient module or control unit.Over-abrading can cause serious topical reaction to the patient.Always apply using the preferred patient preparation technique.Do not touch the electrode sites with your fingers/skin as this may compromise the conductivity between the patient¿s skin and electrode.Connection of a patient to electrosurgical equipment and to the nvm5 system simultaneously may result in burns at the site of the electrodes and possibly damage the nvm5 system circuitry.Operation of the nvm5 system in close proximity to shortwave or microwave therapy equipment may produce instability in the electrical stimulator output.Do not attempt to repair the nvm5 system.Any malfunction which does not respond to remedies identified in this guide (see ¿troubleshooting¿ section in the quick reference manual) can only be addressed by manufacturer¿s service.We require that the device be returned to nuvasive for any such inspection, service, or repair." ".The nvm5 system will not be able to reliably detect emg impulses on channels degraded by noise.If an impedance test error occurs, immediate attention should be directed toward correcting the problem by checking the electrode placement, securing the electrodes with tape, and eliminating any other sources of the noise.If excessive ambient noise persists or if a noise error message appears, check the position of all leads and electrodes, and position them as far away from other electronic equipment as possible.Observe the emg signals using the free run, or evoked potentials display to determine the nature of the noise.Poor electrode impedance may create susceptibility to electrical interference, which can adversely affect system performance.Connection of the nvm5 system to unapproved equipment may result in dangerous levels of patient leakage currents.Use only approved nuvasive accessories with the nvm5 system.Do not use cables or accessories other than those provided with the system." ".Pre-operative warnings: the methods of use of instruments are to be determined by the user¿s experience and training in surgical procedures.The instruments should be carefully examined prior to use for functionality, excessive wear, or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury.Nuvasive does not and cannot warrant the use of instruments nor any of the component parts upon which repairs have been made or attempted except as performed by nuvasive or an authorized nuvasive repair representative.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.Instruments should be protected during storage and from corrosive environments.All non-sterile parts should be cleaned and sterilized before use.Inspect all components for damage before use.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Method of use: please refer to the nvm5 system product reference manual (doc #9400247) for use of the entire system (software, camera, and accessories).Refer to the instructions for use accompanying other nuvasive devices for proper use of these devices.".

Event Description

Updated information listed on h10.

• 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: 15263566
• MDR Text Key: 303065655
• Report Number: 2031966-2022-00155
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517168603
• UDI-Public: 887517168603
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K162313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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: 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
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/21/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2011
• 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 NEEDLE MODULE, EMG.PN 8050015.LN 1091649.
• Patient Sex: Prefer Not To Disclose