NIM-ResponseRecalls & reported problems across all models
Medtronic Xomed, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 974
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls
- 0
We found 13 models of NIM-Response by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 974 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Sep 28, 2026 — classified as 38 injuries, 936 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (280 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported NIM-Response problems
Device problems
- Use of Device Problem280
- Incorrect, Inadequate or Imprecise Result or Readings261
- False Negative Result109
- Inappropriate Audible Prompt/Feedback63
- Device Sensing Problem61
- Failure to Sense47
- Device Operates Differently Than Expected39
- Break34
Patient problems
- No Clinical Signs, Symptoms or Conditions588
- No Consequences Or Impact To Patient280
- No Known Impact Or Consequence To Patient76
- Nerve Damage20
- No Patient Involvement18
- Insufficient Information6
- Injury4
- Paralysis4
NIM-Response models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NIM-Response® 8253002STIMULATOR, NERVE171 reports
- NIM-Response® 8253001STIMULATOR, NERVE154 reports
- NIM-Response® 8253200STIMULATOR, NERVE150 reports
- NIM-Response® 8253200STIMULATOR, ELECTRICAL, EVOKED RESPONSE113 reports
- NIM-Response® 8253002STIMULATOR, NERVE105 reports
- NIM-Response® 8253200STIMULATOR, NERVE100 reports
- NIM-Response® 8253001STIMULATOR, ELECTRICAL, EVOKED RESPONSE66 reports
- NIM-Response® 8253001STIMULATOR, NERVE65 reports
- NIM-Response® 8253001RFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE24 reports
- NIM-Response® 8253001STIMULATOR, ELECTRICAL, EVOKED RESPONSE16 reports
- NIM-Response® 8253200RFSTIMULATOR, NERVE7 reports
- NIM-Response® 8253210STIMULATOR, ELECTRICAL, EVOKED RESPONSE2 reports
- NIM-Response® 8253001LOSTIMULATOR, ELECTRICAL, EVOKED RESPONSE1 report
Recent NIM-Response adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026False Negative Result
It was reported that during surgery, the mainframe were not getting any feedback when stimulating. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911109 ↗MalfunctionSep 28, 2026Inappropriate Audible Prompt/Feedback
It was reported that the mainframe is giving reactive noise. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911022 ↗MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880080 ↗MalfunctionSep 18, 2026False Negative Result
It was reported that during Goiter removal procedure, the system is "not reading correctly"-- no clarification could be confirmed. Site swapped to another system to complete the surgery. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813520 ↗MalfunctionSep 17, 2026Inappropriate Audible Prompt/Feedback
It was reported that pre op there was a great interference occurred from the patient interface. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50798285 ↗MalfunctionSep 1, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541769 ↗MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50493560 ↗MalfunctionAug 4, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50126506 ↗MalfunctionJul 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50048736 ↗MalfunctionJun 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BEFORE OPERATION, THE NIM PATIENT INTERFACE WAS NOT PROVIDING STIMULATION RESPONSE. SYSTEM PASSED ELECTRODE CHECK BEFORE ENTERING INTO THE MONITORING SCREEN. RETURN STIMULUS WAS DISPLAYED AS "0", THERE WAS NO AUDIBLE FEEDBACK NOR A WAVEFORM GOT DISPLAYED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25617696 ↗MalfunctionJun 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF THE DEVICE, THE CUSTOMER OBSERVED THAT ONE VOCAL CORD WAS ONLY INTERMITTENTLY DETECTED, RESULTING IN THE INDICATOR LIGHT ALTERNATING BETWEEN GREEN AND RED. REPOSITIONING THE ENDOTRACHEAL TUBE DID NOT RESOLVE THE ISSUE. TO ISOLATE THE SOURCE OF THE MALFUNCTION, PERFORMED A TEST WITH ANOTHER PACEMAKER USING THE SAME ACCESSORIES: NO DEFECTS WERE FOUND, LEADING US TO CONCLUDE THAT THE FAILURE IS INDEED ATTRIBUTABLE TO THE MAINFRAME, USED ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25499037 ↗MalfunctionJun 15, 2026Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT NIM MAINFRAME WAS SOUNDING WITH UNEXPECTED NOISE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25498501 ↗MalfunctionJun 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING SET-UP, THE PATIENT INTERFACE HAD NO RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25498386 ↗MalfunctionJun 15, 2026Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT PRE-OP, THE SIGNAL INTERFERENCES WERE OBSERVED. NO TROUBLESHOOTING WAS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25498272 ↗MalfunctionJun 13, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, NIM SYSTEM HAD NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25494700 ↗
Other Medtronic Xomed, Inc. products
All Medtronic Xomed, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page