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

Model Number NVM5MULTI

Device Problem Failure to Read Input Signal (1581)

Patient Problem Nerve Proximity Nos (Not Otherwise Specified) (2647)

Event Type  malfunction  

Manufacturer Narrative

Product was returned and investigation was performed.Latest logs saved were from october and event was reported in december.Edge cards were replaced unrelated to reported event.Power cycled unit 3 times and ran dynamic stim tests without any issues.

Event Description

As per reporter device provided inaccurate readings and screw breach was noted during x-ray review.It is unknown if patient underwent a revision procedure or if screw breach was addressed intra-operative.

• Brand Name: NUVASIVENVM5 SYSTEM
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk boulevard; san diego 92121 ; 8589093383
• MDR Report Key: 8276762
• MDR Text Key: 135356284
• Report Number: 2031966-2019-00156
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517089175
• UDI-Public: 887517089175
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NVM5MULTI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1