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U.S. Department of Health and Human Services

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

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NUVASIVE, INC. NUVASIVE NVM5 SYSTEM ELECTROMYOGRAPHY (EMG) MONITOR/STIMULATOR Back to Search Results
Model Number NVM5
Device Problems Display (416); Electrical /Electronic Property Problem (1198)
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 patient's neural anatomy. Following the aborted surgery, the patient 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, information was obtained that indicated the device function was related to the patient's unresolved neurological deficits.

 
Manufacturer Narrative

Nuvasive reference (b)(4). The initial complaint did not indicate an injury had occurred. It was reported that two devices were used during the attempted surgery (b)(4). Records for device (b)(4) indicate it was not released for use until (b)(4) 2012; the device was not available for use on (b)(4) 2012. (b)(4) was evaluated on 02/29/2012 following the report; no malfunction was noted. The device was returned to service on 03/12/2013. Additional information received 06/04/2013 alleges the device caused/contributed to the patient'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 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 safe placement of instruments, the procedure should be suspended. ".

 
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Brand NameNUVASIVE NVM5 SYSTEM
Type of DeviceELECTROMYOGRAPHY (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 Key3204436
MDR Text Key16753515
Report Number2031966-2013-00033
Device Sequence Number1
Product Code ETN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK112718
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 06/26/2013,06/11/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNVM5
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/21/2013
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/28/2012
Device Age5 yr
Event Location Hospital
Date Manufacturer Received06/04/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/22/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/28/2013 Patient Sequence Number: 1
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