NVM5 2023000Recalls & reported problems

Nuvasive, Inc. · NVM5 Control Unit- 3 · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517957368), received between Oct 16, 2024 and Oct 16, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Deliver Shock/Stimulation1

Patient problems

Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 16, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
IT WAS REPORTED THAT A FACILITY USING NEUROMONITORING DURING A PROCEDURE WAS UNABLE TO ELICIT ADEQUATE NERVE RESPONSE SIGNALS DURING EQUIPMENT SET-UP FROM A PATIENT FOLLOWING A SUCCESSFUL TWITCH TEST. THE ISSUE WAS UNABLE TO BE RESOLVED AND THE PROCEDURE WAS STOPPED AND RESCHEDULED FOR ON (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 20466992 ↗

Device details

UDI-DI	`00887517957368`
Brand	NVM5
Model	2023000
Company	Nuvasive, Inc.
Product code	PDQ · Neurosurgical nerve locator
Class	Class 2
FDA submission	K162313
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 11, 2025

Device type (GMDN): Neurophysiologic monitoring system

An assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.