N/A 8227415Recalls & reported problems

Medtronic Xomed, Inc. · ELECTRODE 8227415 5PK PRASS PRD 4CH ROHS · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 20763000038209), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inappropriate Audible Prompt/Feedback” (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

Inappropriate Audible Prompt/Feedback1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionApr 3, 2026Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT INTRA-OP, NIM 3.0 WAS NOISY, SHOWED IRREGULARITIES DURING MONITORING PROBABLY DUE TO INCORRECT DEVICE SETTING. USER REPLACED THE ELECTRODES AND THE STIMULATOR, RESTARTED THE DEVICE AND THE ISSUE RESOLVED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24773752 ↗

Device details

UDI-DI	`20763000038209`
Brand	N/A
Model	8227415
Company	Medtronic Xomed, Inc.
Product code	GXZ · ELECTRODE, NEEDLE
Class	Class 2
FDA submission	K850107
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 1, 2021

Device type (GMDN): Electromyographic needle electrode, single-use

A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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