Devices › Stimulator, hypoglossal nerve, implanted, apnea
Device brand name · Inspire model 3028 ipg
Inspire Model 3028 IPG: medical device reports filed with FDA
1,437 reports name it, 2018–2026. Manufacturer given most often on reports: Inspire Medical Systems. Product code MNQ.
- 1,437
- device reports naming the brand
- 0% of all MAUDE reports · about 171 a year
- 298
- reports, 12 months to August 2026
- 375 in the 12 months before
- 0.3%
- classified as malfunction
- 4.5% across the product code
- 0.3%
- classified as death, as reported
- 4 reports · not verified by FDA
1,437 medical device reports received by FDA name the brand "Inspire Model 3028 IPG" (inspire model 3028 ipg); the manufacturer given most often on reports is Inspire Medical Systems; received from February 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
298 reports arrived in the 12 months to August 2026, down 21% from 375 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 injury (99.4%), death (0.3%) and malfunction (0.3%); across all stimulator, hypoglossal nerve, implanted, apnea reports (product code MNQ) death is recorded in 0.1% and malfunction in 4.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration (8.8%), migration or expulsion of device (3%) and expulsion (0.7%). The patient problems coded most often are pain, wound dehiscence and hematoma. 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 3,571 reports carrying product code MNQ. 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 |
|---|---|---|---|
| Migrationthe device moved from where it was placed | 127 | 8.8% | 6% |
| Migration or expulsion of device | 43 | 3% | 4.6% |
| Expulsion | 10 | 0.7% | 1.4% |
| Material twisted/bent | 9 | 0.6% | 0.5% |
| Insufficient device problem information | 5 | 0.3% | 0.4% |
| Device sensing problem | 3 | 0.2% | 3.3% |
| Material split, cut or torn | 3 | 0.2% | 0.2% |
| Device dislodged or dislocated | 2 | 0.1% | 0.2% |
| Malposition of device | 2 | 0.1% | 1% |
| Corrodedthe device corroded | 1 | 0.1% | 0% |
| Detachment of device or device componentpart of the device came off | 1 | 0.1% | 0.5% |
| Improper or incorrect procedure or method | 1 | 0.1% | 0.3% |
| Loosening of implant not related to bone-ingrowth | 1 | 0.1% | 0% |
| Patient device interaction problem | 1 | 0.1% | 0.4% |
| Therapeutic or diagnostic output failure | 1 | 0.1% | 0.4% |
| Unintended electrical shock | 1 | 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 |
|---|---|---|
| Painpain, site not specified | 465 | 32.4% |
| Wound dehiscencea wound reopened | 170 | 11.8% |
| Hematomaa collection of blood under the skin or in tissue | 160 | 11.1% |
| Erosion | 102 | 7.1% |
| Inflammationinflammation | 83 | 5.8% |
| Swelling/ edema | 80 | 5.6% |
| Seromaa collection of fluid under the skin | 60 | 4.2% |
| Purulent discharge | 55 | 3.8% |
| Bacterial infectiona bacterial infection | 43 | 3% |
| Fluid discharge | 39 | 2.7% |
| Implant pain | 39 | 2.7% |
| Perforation of vessels | 29 | 2% |
| Skin inflammation/ irritation | 24 | 1.7% |
| Twiddlers syndrome | 20 | 1.4% |
| Cellulitisa skin infection | 15 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Inspire Model 3028 IPG | Product code MNQ | All MAUDE reports |
|---|---|---|---|
| Reports | 1,437 | 3,571 | 26,136,888 |
| Share of that pool | — | 40.2% | 0% |
| Classified as death, per 1,000 reports | 3 | 1 | 9 |
| Classified as injury | 99.4% | 95.3% | 36.2% |
| Classified as malfunction | 0.3% | 4.5% | 62.3% |
| Filed by the manufacturer | 99.9% | 95% | 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 MNQ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Inspire Model 4063 Stimulation Lead | 1,313 | 426 | 0% |
| Inspire Model 4340 Respiratory Sensing Lead | 272 | 36 | 0% |
| Inspire V IPG Model 3150 | 166 | 163 | 0% |
| Dexcom G7 | 1,394 | 583 | 0.1% |
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 Inspire Model 3028 IPG reports
How many FDA reports name Inspire Model 3028 IPG?
1,437 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 298 in the latest 12 months.
What kinds of events are reported?
injury (99.4%), death (0.3%) and malfunction (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration (8.8%), migration or expulsion of device (3%), expulsion (0.7%), material twisted/bent (0.6%) and insufficient device problem information (0.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Inspire Model 3028 IPG 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.