MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE NEXT GENERATION NVM5 SYSTEM; NEUROSURGICAL NERVE LOCATOR22

Model Number NVM5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Spinal Cord Injury (2432)

Event Date 01/07/2021

Event Type  Injury  

Manufacturer Narrative

No device was returned to nuvasive for evaluation as no malfunction was observed.No radiographs were provided so the complaint could not be confirmed.No patient information or history was provided.Review of the reported event noted that the monitoring system identified the injury took place and the surgeon was appropriately notified.No additional investigation required.Labeling review: ".Contraindications: the nvm5 system may not be effective, and is not intended for use, when neuromuscular block or epidural blocks have been used for, or in conjunction with, anesthesia.Contraindications to use of motor evoked potential (mep) monitoring include epilepsy, cortical lesions, convexity skull defects, raised intracranial pressure, cardiac disease, proconvulsant medications or anesthetics, intracranial electrodes, vascular clips or shunts, and cardiac pacemakers or other implanted biomedical devices.Otherwise unexplained intraoperative seizures and possibly arrhythmias are indications to abort mep.Neuromuscular block or paralytics should not be in effect during the use of nvm5 emg as they might interfere with the electromyography readings." ".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.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." ".Intra-operative warnings: the physician should take precautions against putting undue stress on the spinal area with instruments.Any surgical technique should be carefully followed.It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the patient.".

Event Description

On (b)(6) 2021, c2-t1 psf.Np stated that mep/ssep responses were stable at the beginning of closing.Np stated that toward the end of closing, meps/sseps were almost completely lost.Np immediately informed surgeon and had anesthesia increase map, with no improvement in responses.Once np had reached out, closing was at skin and monitoring had stopped.Np stated that patient woke up with deficits.An mri was performed and cord edema was discovered.Patient in icu on corticosteroids.

• Brand Name: NUVASIVE NEXT GENERATION NVM5 SYSTEM
• Type of Device: NEUROSURGICAL NERVE LOCATOR22
• 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: george panfili ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 11272787
• MDR Text Key: 230104513
• Report Number: 2031966-2021-00023
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517079855
• UDI-Public: 887517079855
• 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,health
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 02/03/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: NVM5
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization