NA 5140-508-280Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · C2 NerveMonitor, 8 Channel · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327277319), received between Jan 9, 2018 and Aug 27, 2019 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Sensing Problem” (2 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 18, 2026.
Most reported problems
Device problems
- Device Sensing Problem2
- Failure to Sense1
- Noise, Audible1
Patient problems
- Nerve Damage2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2019Failure to Sense; Noise, Audible; Failure to Sense; Noise, Audible
IT WAS REPORTED THAT WHILE ELECTROCAUTERY WAS IN USE DURING A PROCEDURE, THE MONITOR WAS ERRATICALLY BEEPING AND HAD A LOSS OF RECORDING CHANNEL. THESE CONDITIONS, IN WHICH THE DEVICE IS DELIVERING ADDITIONAL AUDIBLE INDICATION OR HAS AN INACCURATE VISIBLE DISPLAY, MAY BE MISUNDERSTOOD BY THE USER, POSING INCREASED RISK OF NERVE INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8934555 ↗InjuryJul 9, 2019Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE SURGEON HEARD A NERVE CONFIRMATION TONE WHEN STIMULATING THE LARYNX, BUT DID NOT HEAR A TONE WHEN STIMULATING OTHER TISSUE. IT WAS REPORTED THAT THE SURGEON VERIFIED THE NERVE WAS INTACT; HOWEVER, FOLLOWING THE PROCEDURE, THE VOCAL CORDS WERE INJURED AND WOULD NOT MOVE.
Patient problems: Nerve Damage
MAUDE report 8771189 ↗InjuryJan 9, 2018Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE DID NOT RECORD NERVE ACTIVITY, AND THE SURGEON PROCEEDED TO CUT A NERVE. IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED.
Patient problems: Nerve Damage
MAUDE report 7174481 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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