MAUDE Adverse Event Report: NUVASIVE, INC NUVASIVENVM5 SYSTEM; NEUROSURGICAL NERVE LOCATOR

Model Number NVM5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation as no product malfunction has been alleged.No root cause can be confirmed at this time.

Event Description

On (b)(6) 2020, patient underwent a spinal procedure where the nvm5 system and mep were used.On (b)(6) 2020 it was reported that the patient had not yet woken up from the anesthesia.As per reporter patient has reportedly woken up since.

• Brand Name: NUVASIVENVM5 SYSTEM
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE, INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: virnalisa cobacha ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 9802432
• MDR Text Key: 183102596
• Report Number: 2031966-2020-00035
• Device Sequence Number: 1
• Product Code: PDQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: NVM5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization