N/A 8225401Recalls & reported problems
Medtronic Xomed, Inc. · PROBE 8225401 5PK SD-SD BIPOL STIM ROHS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20763000038407), received between Sep 30, 2022 and Jan 28, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (3 reports).
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 Result3
- Incorrect, Inadequate or Imprecise Result or Readings3
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings
ADDITIONAL INFORMATION STATES THAT 2 PRODUCTS OF SAME LOT IN THAT BOX HAVE BEEN USED WITH OUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21249855 ↗MalfunctionJan 28, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT NOT WORKING, NO REACTION. TRIED 2 OF THEM OF THE SAME LOT AND THEY DIDN'T RESPOND. USED A DIFFERENT LOT NUMBER THAT WORKED DURING CASE. NO PATIENT IMPACT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21249852 ↗MalfunctionJan 28, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings
ADDITIONAL INFORMATION STATES THAT 2 PRODUCTS OF SAME LOT IN THAT BOX HAVE BEEN USED WITH OUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21249669 ↗MalfunctionSep 30, 2022Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT NERVE STIMULATOR PROBE WAS DEFECTIVE. DOCTOR ATTEMPTED TO USE PROBE TO VERIFY SUSPECTED NERVE STRUCTURES BUT THE SYSTEM DID NOT GIVE ANY INDICATION OF A RESPONSE. THEY VERIFIED ALL SETTINGS AND CONNECTIONS WERE CORRECT WITH NO CHANGE. THE PROBE WAS REPLACED WITH A NEW PROBE WHICH WORKED AS EXPECTED. PROCEDURE CONTINUED AS NORMAL. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15511446 ↗
Other STIMULATOR, NERVE devices
- NIM Vital NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls260 reports
- NIM TriVantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls176 reports
- NIM® 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall1 death167 reports
- NIM Vital™ NIM4CPB1Medtronic Xomed, Inc. · STIMULATOR, NERVE3 recalls45 reports
- NIM Trivantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall142 reports
- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall138 reports
- NIM TriVantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls78 reports
- NIM-Response® 8253002Medtronic Xomed, Inc. · STIMULATOR, NERVE171 reports
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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