NA 5140-510-025Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Mute Sensor · Class 2
Data updated Oct 18, 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 07613327299878), received between Aug 27, 2019 and Aug 27, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Sense” (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 18, 2026.
Most reported problems
Device problems
- Failure to Sense1
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 27, 2019Failure to Sense; Failure to Sense
DURING A PROCEDURE IN WHICH THE MUTE SENSOR WAS IN USE WITH THE NERVE MONITOR, IT WAS REPORTED THAT THERE WAS NOT ENOUGH AUDIO FEEDBACK BEING MUTED. THIS CONDITION, IN WHICH THE DEVICE IS DELIVERING ADDITIONAL AUDIBLE INDICATION, MAY BE MISUNDERSTOOD BY THE USER, POSING INCREASED RISK OF NERVE INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8934559 ↗
Other STIMULATOR, ELECTRICAL, EVOKED RESPONSE devices
- NIM Vital™ NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 recalls795 reports
- NIM Vital™ NIM4CPB1Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 recalls331 reports
- NIM Vital NIM4CPB1Medtronic Xomed, Inc. · Stimulator, electrical, evoked response2 recalls208 reports
- POWEREASE™ Instruments 2300000Medtronic Sofamor Danek, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE1 recall203 reports
- NIM Vital™ NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 recalls47 reports
- NIM-Response® 8253200Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE113 reports
- NA DAQ916Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE80 reports
- Neuromaster G1 DC-200BNihon Kohden Corporation · STIMULATOR, ELECTRICAL, EVOKED RESPONSE73 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.
How reports and recalls are matched · Editorial policy · Report an error on this page