Stimulator, nerve: medical device reports filed with FDA

5,123 reports carry this product code, 1992–2026; 14 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

5,123
reports with this product code: 0% of all MAUDE reports; 611
reports, 12 months to August 2026: 1,182 in the 12 months before; 83.4%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code ETN is FDA's classification for "Stimulator, nerve" (ear, Nose, Throat panel), a class 2 device. 5,123 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

611 reports arrived in the 12 months to August 2026, down 48% from 1,182 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (83.4%), injury (15.8%) and other (0.3%). 14 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Nim Emg - Endotracheal Tube - Trivantage	976	224	0.1%	84.3%
Nim Emg - Endotracheal Tube	540	1	0.6%	68.7%
Nim 3 0 Mainframe International	533	69	0%	96.1%
Nim 3 0 Interface	440	48	0%	99.4%
Nim 3 0 Mainframe	384	39	0%	91.4%
Nim Probe	369	78	0%	93%
Nim-Neuro 3 0 Mainframe	201	38	0%	97.2%
Nim Emg - Endotracheal Tube - Nim Flex	170	39	0%	77.1%
Nim Vital Patient Interface 4 Channel	51	123	0%	100%
Patient Interface Nim4cpb1 Nim 4 0	19	122	0%	100%
Nim 4 0 Console	16	528	0%	97.4%
Medtronic	2	17	4.4%	23.5%
Nuvasive Reline System	1	8	1.5%	71.2%
Viking	1	1	5%	49.7%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Xomed	3,888	75.9%
Medtronic Dominicana	695	13.6%
Covidien	43	0.8%
Nuvasive	19	0.4%
Warsaw Orthopedic	5	0.1%
Stryker Spine-US	2	0%
Advanced Neuromodulation Systems	1	0%
Mdt Powered Surgical Solutions	1	0%
Medtronic Sofamor Danek USA	1	0%
Stryker Instruments	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.2%11

Injury15.8%811

Malfunction83.4%4,274

Other0.3%16

Not given0.2%11

Who filed

Manufacturer report96.6%4,948

Voluntary report1.1%58

User facility report0%0

Distributor report0.1%4

Not given2.2%113

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Incorrect, inadequate or imprecise result or readings	1,371	26.8%
Unintended deflation	452	8.8%
Device operates differently than expectedthe device behaved unexpectedly	424	8.3%
False negative result	360	7%
Inappropriate audible prompt/feedback	266	5.2%
Failure to sense	197	3.8%
Device sensing problem	193	3.8%
Breakthe device broke	149	2.9%
Obstruction of flow	129	2.5%
Leak/splashthe device leaked	123	2.4%
Unable to obtain readings	107	2.1%
Air leak	65	1.3%
Noise, audible	65	1.3%
Material puncture/hole	61	1.2%
Failure to power up	60	1.2%
Sensing intermittently	58	1.1%
False positive result	56	1.1%
Inflation problem	56	1.1%
Circuit failure	42	0.8%
Application program freezes or fails to launch	40	0.8%

Questions about stimulator, nerve reports

What is product code ETN?

FDA's classification code for "Stimulator, nerve", class 2, reviewed by the ear, Nose, Throat panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,123 reports through August 2026, 611 of them in the latest 12 months.

Which brands appear most often?

Nim Emg - Endotracheal Tube - Trivantage (976), Nim Emg - Endotracheal Tube (540), Nim 3 0 Mainframe International (533), Nim 3 0 Interface (440) and Nim 3 0 Mainframe (384). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.