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NA 8227411 (UDI 00643169695009)Recalls & reported problems

Medtronic Xomed, Inc. · ELECTRODE 8227411 PAIRED 4 CH SET ROHS · 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 00643169695009), received between Aug 31, 2017 and Aug 31, 2017 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • False Negative Result1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionAug 31, 2017False Negative Result; False Negative Result

    THE FACILITY REPORTED THAT THE WHEN THE DEVICE WAS STIMULATED, THERE WAS NO SENSING. THE NERVE LOCATION WAS KNOWN BUT THE DEVICE WAS NOT DETECTING THE NERVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SET OF ELECTRODES. THERE WAS NO PATIENT IMPACT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6835396 ↗

Other ELECTRODE, NEEDLE devices

All ELECTRODE, NEEDLE devices →

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