MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE PULSE SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 1881500

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Event Description

During an extreme lumbar interbody fusion on the l4-5 while using electromyography (emg) on a surgical dilator, the system notified the surgeon that the dilator was in close proximity to a nerve in every direction tested, which the surgeon believed to be incorrect.No patient harm was reported as a result of the reported event.

Manufacturer Narrative

An on-site company representative was permitted to troubleshoot the system during the case and was able to confirm the reported event.The device has been used by the site since the reported event with the on-site company representative reporting they have seen no further emg monitoring issues.No device was returned for evaluation.Based on the information obtained the root cause of the reported event is unable to be determined, but may be the result of signal interference between the stimulation and recording electrodes on the patient as a result of patient anatomy and electrode placement.Labeling review: "warnings, cautions, and precautions.While the pulse 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." ".To optimize accuracy of emg recording, the emg common electrode should be located between the site of stimulation and the recording electrodes." ".While a positive emg detection by the pulse 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." ".Movement of the patient during stimulation can cause excessive electrical ¿noise¿ and/or false emg (noise) artifacts.".

• Brand Name: NUVASIVE PULSE SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 15655267
• MDR Text Key: 306891600
• Report Number: 2031966-2022-00218
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00887517990792
• UDI-Public: 887517990792
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1881500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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 Sex: Prefer Not To Disclose