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

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

Patient Problems Pain (1994); Paralysis (1997); Hypoesthesia, Foot/Leg (2354)

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation as it remains in-situ.As per reporter no product malfunction was reported to her at the time of procedure nor has in the post-operative phase.No other information has become available.No product malfunction.

Event Description

Received information from patient that alleged motor function in her legs has been affected post index surgery.Patient has regained motor function in her left leg, but the right leg is still affected and requires use of a wheelchair for transportation.No allegation of product malfunction has been reported.

• 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: yobana sanchez ; 7475 lusk blvd; san diego, CA 92121 ; 8589093383
• MDR Report Key: 7511327
• MDR Text Key: 108164451
• Report Number: 2031966-2018-00055
• Device Sequence Number: 1
• Product Code: PDQ
• Combination Product (y/n): N
• PMA/PMN Number: K152942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability