Devices › Stimulator, electrical, evoked response
Device brand name · Stimulator electrical evoked response
Nim 4 0 Console: medical device reports filed with FDA
1,438 reports name it, 2022–2026. Manufacturer given most often on reports: Medtronic Xomed. Product code GWF.
- 1,438
- device reports naming the brand
- 0% of all MAUDE reports · about 360 a year
- 528
- reports, 12 months to August 2026
- 579 in the 12 months before
- 97.4%
- classified as malfunction
- 96.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,438 reports that name the brand "Nim 4 0 Console" (stimulator electrical evoked response), received between July 2022 and August 2026; the manufacturer given most often on reports is Medtronic Xomed. Spellings of one product vary from report to report.
528 reports arrived in the 12 months to August 2026, close to the 579 of 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 (97.4%) and injury (2.6%); across all stimulator, electrical, evoked response reports (product code GWF) death is recorded in 0% and malfunction in 96.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect, inadequate or imprecise result or readings (62.6%), inappropriate audible prompt/feedback (17%) and false negative result (15.1%). The patient problems coded most often are nerve damage, facial paralysis and paralysis. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,308 reports carrying product code GWF. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Incorrect, inadequate or imprecise result or readings | 900 | 62.6% | 49.5% |
| Inappropriate audible prompt/feedback | 244 | 17% | 9.1% |
| False negative result | 217 | 15.1% | 8.2% |
| Failure to power up | 111 | 7.7% | 4.1% |
| False positive result | 86 | 6% | 3.1% |
| Computer software problema software problem | 84 | 5.8% | 3.4% |
| Application program freezes or fails to launch | 50 | 3.5% | 1.9% |
| Signal artifact/noise | 36 | 2.5% | 1.5% |
| Problem with software installation | 35 | 2.4% | 1.6% |
| Connection problema connection problem | 32 | 2.2% | 2.4% |
| Battery problema problem with the battery | 30 | 2.1% | 1.3% |
| Incomplete or inadequate connection | 28 | 1.9% | 1.8% |
| Device misassembled during manufacturing /shipping | 10 | 0.7% | 0.4% |
| Breakthe device broke | 8 | 0.6% | 1.6% |
| Noise, audible | 7 | 0.5% | 0.2% |
| Electrical /electronic property probleman electrical or electronic problem | 6 | 0.4% | 1.2% |
| Communication or transmission problemthe device could not communicate or transmit | 4 | 0.3% | 0.5% |
| Unexpected shutdown | 4 | 0.3% | 0.3% |
| Fitting problem | 3 | 0.2% | 0.1% |
| Electrical shorting | 2 | 0.1% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Nerve damage | 24 | 1.7% |
| Facial paralysis | 8 | 0.6% |
| Paralysis | 8 | 0.6% |
| Electric shockan electric shock | 4 | 0.3% |
| Paresis | 3 | 0.2% |
| Unintended extubation | 3 | 0.2% |
| Hemorrhage/blood loss/bleeding | 2 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.1% |
| Speech disordera speech problem | 1 | 0.1% |
| Twitching | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Nim 4 0 Console | Product code GWF | All MAUDE reports |
|---|---|---|---|
| Reports | 1,438 | 3,308 | 26,136,888 |
| Share of that pool | — | 43.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 2.6% | 3.4% | 36.2% |
| Classified as malfunction | 97.4% | 96.1% | 62.3% |
| Filed by the manufacturer | 100% | 98.1% | 94.9% |
Shares are of reports, not of devices in use. 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."
Other brands with product code GWF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Patient Interface Nim4cpb1 Nim 4 0 | 298 | 122 | 0% |
| Nim-Eclipse Controller | 221 | 33 | 0% |
| Nim Vital Patient Interface 4 Channel | 209 | 123 | 0% |
| Nim-Eclipse Preamplifier | 153 | 35 | 0% |
| Nim 3 0 Interface | 472 | 48 | 0% |
| Nim 3 0 Mainframe International | 560 | 69 | 0% |
| Nim 3 0 Mainframe | 407 | 39 | 0% |
| Nim-Neuro 3 0 Mainframe | 212 | 38 | 0% |
| Bravo | 11,648 | 568 | 0% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Nim 4 0 Console reports
How many FDA reports name Nim 4 0 Console?
1,438 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 528 in the latest 12 months.
What kinds of events are reported?
malfunction (97.4%) and injury (2.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect, inadequate or imprecise result or readings (62.6%), inappropriate audible prompt/feedback (17%), false negative result (15.1%), failure to power up (7.7%) and false positive result (6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Nim 4 0 Console was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.