Devices › Implant, anti-gastroesophageal reflux
Device brand name · Anti-reflux implant
1 5t Linx 13b: medical device reports filed with FDA
157 reports name it, 2018–2026. Manufacturer given most often on reports: Torax Medical. Product code LEI.
- 157
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 9
- reports, 12 months to August 2026
- 13 in the 12 months before
- 2.5%
- classified as malfunction
- 4.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 157 reports that name the brand "1 5t Linx 13b" (anti-reflux implant), received between August 2018 and March 2026; the manufacturer given most often on reports is Torax Medical. Spellings of one product vary from report to report.
9 reports arrived in the 12 months to August 2026, down 31% from 13 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 (97.5%) and malfunction (2.5%); across all implant, anti-gastroesophageal reflux reports (product code LEI) death is recorded in 0.1% and malfunction in 4.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device appears to trigger rejection (35.7%), detachment of device or device component (26.8%) and patient device interaction problem (26.8%). The patient problems coded most often are dysphagia/ odynophagia, heartburn/indigestion and pain. 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 2,244 reports carrying product code LEI. 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 |
|---|---|---|---|
| Device appears to trigger rejection | 56 | 35.7% | 30.5% |
| Detachment of device or device componentpart of the device came off | 42 | 26.8% | 13.9% |
| Patient device interaction problem | 42 | 26.8% | 20.3% |
| Migration or expulsion of device | 14 | 8.9% | 8.8% |
| Therapeutic or diagnostic output failure | 7 | 4.5% | 1.9% |
| Material separation | 3 | 1.9% | 0.3% |
| Breakthe device broke | 2 | 1.3% | 0.3% |
| Device-device incompatibility | 2 | 1.3% | 0.8% |
| Nonstandard device | 2 | 1.3% | 0.6% |
| Defective component | 1 | 0.6% | 0.4% |
| Disconnection | 1 | 0.6% | 0.2% |
| Inadequacy of device shape and/or size | 1 | 0.6% | 0% |
| Insufficient device problem information | 1 | 0.6% | 4.2% |
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 |
|---|---|---|
| Dysphagia/ odynophagia | 77 | 49% |
| Heartburn/indigestion | 40 | 25.5% |
| Painpain, site not specified | 19 | 12.1% |
| Vomitingbeing sick | 13 | 8.3% |
| Nauseafeeling sick | 9 | 5.7% |
| Pocket erosion | 9 | 5.7% |
| Cramp(s) /muscle spasm(s) | 7 | 4.5% |
| Hernia | 7 | 4.5% |
| Abdominal distention | 4 | 2.5% |
| Chest painchest pain | 4 | 2.5% |
| Inflammationinflammation | 4 | 2.5% |
| Weight changes | 3 | 1.9% |
| Chokingchoking | 2 | 1.3% |
| Discomfortdiscomfort | 2 | 1.3% |
| Foreign body in patientpart of a device left in the patient | 2 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | 1 5t Linx 13b | Product code LEI | All MAUDE reports |
|---|---|---|---|
| Reports | 157 | 2,244 | 26,136,888 |
| Share of that pool | — | 7% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 97.5% | 94.5% | 36.2% |
| Classified as malfunction | 2.5% | 4.6% | 62.3% |
| Filed by the manufacturer | 100% | 98.4% | 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 LEI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Linx Reflux Management System | 483 | 0 | 0% |
| Unk Linx Magnetic Implant | 396 | 13 | 0.3% |
| 1 5t Linx 14b | 286 | 19 | 0% |
| 1 5t Linx 15b | 273 | 14 | 0% |
| Linx 1 5 16 Bead Us | 183 | 6 | 0.5% |
| Lap-Band Adjustable Gastric Banding System | 2,199 | 0 | 2% |
| Lap-Band Adjustable Gastric Banding System 9 75cm | 1,513 | 0 | 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 1 5t Linx 13b reports
How many FDA reports name 1 5t Linx 13b?
157 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9 in the latest 12 months.
What kinds of events are reported?
injury (97.5%) and malfunction (2.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device appears to trigger rejection (35.7%), detachment of device or device component (26.8%), patient device interaction problem (26.8%), migration or expulsion of device (8.9%) and therapeutic or diagnostic output failure (4.5%). 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 1 5t Linx 13b 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.