N/A 8227414Recalls & reported problems
Medtronic Xomed, Inc. · ELECTRODE 8227414 5PK PRASS PRD 2CH ROHS · Class 2
Data updated Oct 16, 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 20763000038193), received between Mar 6, 2025 and Mar 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
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.
MalfunctionMar 6, 2025False Negative Result; False Negative Result
IT WAS REPORTED WHILE SETTING UP THE NIM FOR THAT CASE IT PASSED ALL THE CHECKS, HOWEVER INTRA-OPERATIVELY THE BLUE CABLE STOPPED TRANSMITTING. TRIED TAPPING THE FACE AND USING THE NIM PROBE BUT GOT NO RESPONSE FROM THAT CABLE/ELECTRODE. ALSO TRIED USING A DIFFERENT BLOCK TO PLUG ALL THE ELECTRODES INTO, CHECKED THE ELECTRODE WAS IN THE CORRECT LOCATION AND SECURE, STARTED THE SET-UP PROCESS OVER, AND REBOOTED THE NIM MACHINE AND IT STILL WASN¿T WORKING. SO OPENED A SECOND PACKET OF ELECTRODES AND THAT BLUE CABLE WORKED PERFECTLY. REPLACED WITH A NEW LEAD AND THE PROCEDURE WAS COMPLETED. THERE WAS EXTENSION FOR 10 MINUTES IN PROCEDURE. NO KNOWN PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21536534 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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