MAUDE Adverse Event Report: NUVASIVE, INCORPORATED STIMULATION?DISSECTION INSTRUMENTS; STIMULATION, NERVE

Model Number	2029950
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned as the device was disposed of at the user facility and no image or data could be provided confirming to the event.No adverse patient consequences or injuries were reported.No root cause could be provided as result of the lack of information provided.However review of the reported event suggest intermittent contact related to technique, cabling connections and/or skin to device conductivity.No additional investigation can be completed.Label review ".Warning: 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." ".Inspect all system components and packaging for damage before use.Do not use sterile components if packaging is opened or damaged.If components are visibly damaged, do not use the system." ".The nvm5 system is to be used only as an adjunct to medical judgment and appropriate surgical practices.Dilator insertion and advancement should be conducted only after careful analysis of radiographic images of the operative target area.While a positive emg detection by the nvm5 system can be associated with a high level of certainty that a nerve is in close proximity to the dilator tip, the absence of such an emg detection cannot be construed as a certain indication that no nerves are close to the dilator tip.Do not advance dilator probes until all available data have been considered.Do not advance the dilator faster than the rate of update of detection data." ".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.".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 #(b)(4)) 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 or Problem Description
On (b)(6) 2022 a patient underwent a lateral interbody fusion procedure on unknown levels of the spine.During the procedure one of the neuro monitoring dilators was experiencing result inconsistencies.The issue was fixed with redocking which resulted in a small surgical delay.The surgery was completed with no adverse consequences to the patient involved.
Event or Problem Description
This is a duplicate of report 2031966 - 2022 - 00223 and follow up report 2031966 - 2022 - 00223 details on sec h10.
Additional Manufacturer Narrative
Patient identifier (b)(6) reported under fda report 2031966 - 2022 - 00222 is the same as patient and event previously reported and investigated under patient identifier (b)(6) fda report 2031966 - 2022 - 00223 main with i follow up report.The same event was accidently reported twice this file can be redacted and reference fda report 2031966 - 2022 - 00223 for completed investigation.

• Brand Name: STIMULATION?DISSECTION INSTRUMENTS
• Common Device Name: STIMULATION, NERVE
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 15670610
• Report Number: 2031966-2022-00222
• Device Sequence Number: 20448628
• Product Code: ETN
• UDI-Device Identifier: 00887517170606
• UDI-Public: 887517170606
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/23/2025
• Device Model Number: 2029950
• Device Lot Number: 2035808
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose