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

Model Number 1637370006

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Numbness (2415); Dysgeusia (4424)

Event Date 06/14/2023

Event Type  Injury  

Manufacturer Narrative

The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique.The root cause of the reported stimulation issue was unable to be determined with the information provided.However, information provided by the complainant noted that a bite-block was not used during the procedure; rather, a roll of gauze was placed in the oral cavity.This is considered off-label use as the label states a bit block must be used to avoid bit injuries.Labeling review: "warning: 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." "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 bite injuries, the patient must be fitted with a bite block before initiating transcranial mep testing.Mep stimulation may induce violent muscle contractions throughout the patient¿s body.Secure physical restraints should be used, and surgical operations should be discontinued before and during mep stimulation.Confirm the surgeon is well notified prior to any mep testing." "exercise caution when increasing max stimulation.Higher stimulation may result in increased patient movement, which may impact retractor position." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent a fixation procedure with neuromonitoring.During the procedure, it was noted that the unit appeared to be malfunctioning and the output stimulation did not exceed 500ma.As a result, the current was increased up to 700ma.Subsequently, when obtaining the mep measurement, the patient experienced a tongue injury.It was noted that a roll of gauze was placed in the oral cavity and no bite block was used.A second neuromonitoring unit was used to complete the procedure with no issues.Approximately two (2) weeks after the procedure, the patient was noted to have mild dysgeusia and numbness and is being monitored.No additional information is available.

Event Description

New information listed on h10.

Manufacturer Narrative

The device was returned to the manufacturer for evaluation on july 28, 2023.The system was tested and no issues issue were related to the reported mep stimulation found.In relation to the reported event, the system was found to be operating as intended.Information provided by the complainant noted that a bite-block was not used during the procedure; rather, a roll of gauze was placed in the oral cavity.This is considered off-label use as the label states a bit block must be used to avoid bite injuries.Labeling review: ".Warning: 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." ".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 bite injuries, the patient must be fitted with a bite block before initiating transcranial mep testing.Mep stimulation may induce violent muscle contractions throughout the patient¿s body.Secure physical restraints should be used, and surgical operations should be discontinued before and during mep stimulation.Confirm the surgeon is well notified prior to any mep testing." ".Exercise caution when increasing max stimulation.Higher stimulation may result in increased patient movement, which may impact retractor position.".

Manufacturer Narrative

Correct date sep 8, 2023.

• Brand Name: NUVASIVE 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: 17303174
• MDR Text Key: 318923566
• Report Number: 2031966-2023-00142
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517069573
• UDI-Public: 887517069573
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143641
• 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,Followup
• Report Date: 10/03/2023

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: 1637370006
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/28/2023; 10/02/2023
• Supplement Dates FDA Received: 09/07/2023; 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: M5 PM3, (B)(6).
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male