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

Model Number 2021030006

Device Problems Circuit Failure (1089); Patient Device Interaction Problem (4001)

Patient Problems Full thickness (Third Degree) Burn (2696); Convulsion/Seizure (4406)

Event Date 08/05/2022

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation, photographs provided confirmed the complaint.Review of the reported event identified unknown bipolar forceps were being used during the procedure with unknown involvement.Surgical notes identified the patient seized during the case with unknown involvement.Due to lack of information provided root cause cannot be determined however, improperly placed or loose electrodes can lead to micro-arcing and burns.No additional investigation can be done.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." "warnings, cautions and precautions: mep stimulation may introduce additional hazards to the patient through use.Examples of these hazards include: tongue or lip laceration, mandibular fracture, seizure, cardiac arrhythmia, and scalp burn.To avoid trans-thoracic stimulation, confirm both mep electrodes are properly attached to the patient¿s scalp or abdomen before initiating any test.The patient may experience skin irritation and burns beneath the stimulation electrodes applied to their skin; and the patient may experience headache and other painful sensations during or following the application of electrical stimulation near their eyes and to their head and face." "compatibility: do not use the nvm5 system with components of other systems.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system." "pre-operative warnings: the methods of use of instruments are to be determined by the user¿s experience and training in surgical procedures.Care should be used during surgical procedures to prevent damage to the devices and injury to the patient.".

Event Description

On (b)(6) 2022 a micro endoscopic discectomy was performed, and electrodes were placed on the head for the use of nvm5.Intraoperatively, the patient had a seizure.There were no abnormalities observed when the electrodes were removed from the head after the surgery was completed.Roughly one week postoperatively, the patient had some discomfort in the head.Later, during follow-up, a grade three burn was confirmed on the patient's head by a dermatologist.

Event Description

Updated for new information listed on h10.

Manufacturer Narrative

A photograph provided confirmed the reported event.The patient module 3 (pm3) and associated nvm5 system were returned for evaluation.Testing of the returned device found the system was unable to deliver motor evoke potential (mep) stimulation.Additional investigation identified damaged components on the stimulation circuit board.The damaged components identified could cause the patient¿s burn by allowing a continuous flow of current to the scalp prior to the system disabling mep stimulation; however, it is unknown if this was the sequence of events that occurred as the device could no longer deliver stimulation current in the condition received.This state is an abnormal condition and is likely the result of the damage sustained to multiple components.Based on the information obtained the root cause of the damaged components is unable to be determined conclusively, but may be related to excessive current delivery from inductive coupling from a electrosurgical diathermy device that was in use, contrary to recommendations in the instruction for use (ifu).Labelling review: ¿contraindications¿ ¿ otherwise unexplained intraoperative seizures and possibly arrhythmias are indications to abort mep.¿ ¿¿ 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¿¿ ¿¿ use of meps is contraindicated in patients with a history of head injury, cerebral aneurysm, stroke, seizures, other neurological impairments, or patients with metal plates or fragments in their head¿¿ ¿¿ 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¿¿ ¿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¿¿ ¿warning¿ ¿ the mep modality is capable of generating outputs exceeding 2ma rms/cm² in every stimulation current (from 200 to 1500ma)/pulse (1 to 8) combination.Prolonged stimulation at outputs greater than 2ma rms/cm² may result in skin burns¿¿ ¿mep stimulation may introduce additional hazards to the patient through use.Examples of these hazards include: tongue or lip laceration, mandibular fracture, seizure, cardiac arrhythmia, and scalp burn¿¿ ¿the patient may experience skin irritation and burns beneath the stimulation electrodes applied to their skin¿¿ ¿precaution¿ ¿ improperly placed corkscrews may result in poor responses or no responses, even with high electrical current stimulus¿¿.

• 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: 15464493
• MDR Text Key: 300382408
• Report Number: 2031966-2022-00188
• Device Sequence Number: 1
• Product Code: PDQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/23/2022

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: 2021030006
• 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: 08/31/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2018
• 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: MEP ELECTRODE(B)(6); MEP ELECTRODE(B)(6); NVM5 CONTROL UNIT(B)(6); UNKNOWN BIPOLAR FORCEPS
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female