Devices › Recorder, event, implantable cardiac, (with arrhythmia detection)
Device brand name · Insertable cardiac monitor
LUX-Dx Insertable Cardiac Monitor: medical device reports filed with FDA
660 reports name it, 2021–2026. Manufacturer given most often on reports: Boston Scientific. Product code MXD.
- 660
- device reports naming the brand
- 0% of all MAUDE reports · about 120 a year
- 83
- reports, 12 months to August 2026
- 79 in the 12 months before
- 10.2%
- classified as malfunction
- 82.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
660 medical device reports received by FDA name the brand "LUX-Dx Insertable Cardiac Monitor" (insertable cardiac monitor); the manufacturer given most often on reports is Boston Scientific; received from January 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
83 reports arrived in the 12 months to August 2026, close to the 79 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 injury (89.8%) and malfunction (10.2%); across all recorder, event, implantable cardiac, (with arrhythmia detection) reports (product code MXD) death is recorded in 0% and malfunction in 82.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are premature discharge of battery (21.4%), communication or transmission problem (7.6%) and signal artifact/noise (5%). The patient problems coded most often are wound dehiscence, erosion and discomfort. 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 12,977 reports carrying product code MXD. 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 |
|---|---|---|---|
| Premature discharge of battery | 141 | 21.4% | 14.8% |
| Communication or transmission problemthe device could not communicate or transmit | 50 | 7.6% | 3.2% |
| Signal artifact/noise | 33 | 5% | 8.5% |
| Migrationthe device moved from where it was placed | 32 | 4.8% | 0.6% |
| False positive result | 31 | 4.7% | 0.4% |
| Under-sensing | 27 | 4.1% | 7.6% |
| Failure to read input signal | 22 | 3.3% | 0.3% |
| Device displays incorrect message | 18 | 2.7% | 0.2% |
| Device sensing problem | 12 | 1.8% | 5.3% |
| Difficult to insertthe device was hard to insert | 8 | 1.2% | 0.1% |
| Malposition of device | 8 | 1.2% | 0.1% |
| Incorrect, inadequate or imprecise result or readings | 7 | 1.1% | 0.2% |
| Defective devicethe device was defective | 6 | 0.9% | 0.1% |
| Difficult or delayed positioning | 6 | 0.9% | 0% |
| Off-label use | 6 | 0.9% | 0% |
| Material integrity problema problem with the device material | 5 | 0.8% | 0.1% |
| Nonstandard device | 5 | 0.8% | 0.1% |
| Over-sensing | 5 | 0.8% | 5.9% |
| Data problem | 4 | 0.6% | 5.3% |
| Human-device interface problem | 4 | 0.6% | 0% |
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 |
|---|---|---|
| Wound dehiscencea wound reopened | 162 | 24.5% |
| Erosion | 47 | 7.1% |
| Discomfortdiscomfort | 36 | 5.5% |
| Painpain, site not specified | 23 | 3.5% |
| Hemorrhage/blood loss/bleeding | 21 | 3.2% |
| Implant pain | 18 | 2.7% |
| Pocket erosion | 13 | 2% |
| Impaired healingslow healing | 9 | 1.4% |
| Twiddlers syndrome | 9 | 1.4% |
| Fluid discharge | 6 | 0.9% |
| Rashskin rash | 5 | 0.8% |
| Swelling/ edema | 5 | 0.8% |
| Hypersensitivity/allergic reaction | 4 | 0.6% |
| Bacterial infectiona bacterial infection | 3 | 0.5% |
| Burning sensationa burning feeling | 3 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | LUX-Dx Insertable Cardiac Monitor | Product code MXD | All MAUDE reports |
|---|---|---|---|
| Reports | 660 | 12,977 | 26,136,888 |
| Share of that pool | — | 5.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 89.8% | 17.2% | 36.2% |
| Classified as malfunction | 10.2% | 82.8% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 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 MXD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| BIOMONITOR IIIm | 435 | 66 | 0% |
| Biomonitor 2-Af | 231 | 0 | 0.4% |
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 LUX-Dx Insertable Cardiac Monitor reports
How many FDA reports name LUX-Dx Insertable Cardiac Monitor?
660 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 83 in the latest 12 months.
What kinds of events are reported?
injury (89.8%) and malfunction (10.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
premature discharge of battery (21.4%), communication or transmission problem (7.6%), signal artifact/noise (5%), migration (4.8%) and false positive result (4.7%). 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 LUX-Dx Insertable Cardiac Monitor 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.