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

Model Number	2010014
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Anaphylactic Shock (1703)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received concerning this event.No device was returned to nuvasive for evaluation; further, operative notes and/or lab results were not provided for review.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided.Labeling review: ".Warnings: 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; keep electrodes out of the reach of children; replace self-adhesive electrodes if they no longer stick firmly to the patient¿s skin.The patient may experience skin irritation and burns beneath the stimulation electrodes applied to their skin." ".The nvm5 disposable accessories are single-use devices supplied sterile.Sterile, single-use only products should not be re-sterilized.Do not use if package is opened or damaged.Do not use if the product is damaged in any way.The nvm5 disposable accessories and nvm5 reusable accessories may only be used with the nuvasive nvm5 system." ".Precaution: the long-term effects of cutaneous electrodes for electrical stimulation and/or recording are unknown.Proper handling, insertion and placement of electrodes is critical for monitoring.Do not use sterile components if packaging is opened or damaged.If components are visibly damaged, do not use the system." ".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.In preparing the sites for emg electrode placement, patient sensitivity to disinfecting and sterilizing agents (e.G., alcohol, povidine, etc.), electrode materials, and adhesive tapes and electrode backings should be considered to prevent skin reactions.Over-abrading can cause serious topical reaction to the patient.Always apply using the preferred patient preparation technique." ".Pre-operative warnings: the methods of use of instruments are to be determined by the user¿s experience and training in surgical procedures.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial extreme lateral interbody fusion procedure at l4/5.During the procedure, after the dual gel electrodes were placed on the patient, the patient went into anaphylactic shock.The procedure was stopped and the patient's condition was reported to have subsided.The surgery was aborted and is planned to be rescheduled after testing for the causative agent of the allergy is conducted.The results of the allergy testing were requested but are not available at this time.No further patient impact was reported.No additional information was available.

• Brand Name: NUVASIVE NVM5 SYSTEM
• Common Device Name: 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: 17848433
• Report Number: 2031966-2023-00214
• Device Sequence Number: 7192555
• Product Code: PDQ
• UDI-Device Identifier: 00887517699213
• UDI-Public: 887517699213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2010014
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose