MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE NVM5 SYSTEM ELECTROMYOGRAPHY (EMG) MONITOR/STIMULATOR

Model Number NVM5

Device Problem Electrical Power Problem (2925)

Patient Problems Fall (1848); Neurological Deficit/Dysfunction (1982)

Event Date 02/28/2012

Event Type  Injury  

Event Description

The device was noted to display electrical interference during xlif surgery (b)(6) 2013 at the l4-l5 disc space. Device was exchanged. The surgery was reported to have been aborted due to the pt's neutral anatomy. Following the aborted surgery, the pt was noted to have neuromotor and neurosensory deficits on the left anterior/lateral/medial thigh, medial calf and medial portion of the foot that were not believed to be due to device operation. On (b)(6) 2013, info was obtained that indicated the device function was related to the pt's unresolved neurological deficits.

Manufacturer Narrative

(b)(4). The initial complaint did not indicate an injury had occurred. It was reported that two devices were used during the attempted surgery (dm50034 and dm50099). Add'l info received (b)(6) 2013 alleges the device caused/contributed to the pt's neurological deficits. 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. " "caution: while the nvm5 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 a thorough knowledge of spinal anatomy and appropriate surgical technique, nor should the info 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 fo electrical interference, and other pt and environmental factors, may influence the operation. If, in the judgement of the clinician, this resistance is sufficient to preclude safe placement of instruments, the procedure should be suspended. ".

• Brand Name: NUVASIVE NVM5 SYSTEM
• Type of Device: ELECTROMYOGRAPHY (EMG) MONITOR/STIMULATOR
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: paul holbrook ; 7475 lusk blvd.; san diego, CA 92121 ; 8583205285
• MDR Report Key: 3251777
• MDR Text Key: 3625608
• Report Number: 2031966-2013-00034
• Device Sequence Number: 1
• Product Code: ETN
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K112718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/03/2013

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/03/2013
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: NVM5
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 05/21/2013
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2012
• Device Age: 54 mo
• Event Location: Hospital
• Date Manufacturer Received: 06/04/2013
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 11/10/2008
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data

Patient TREATMENT DATA

Date Received: 07/03/2013 Patient Sequence Number: 1