Devices › Recorder, event, implantable cardiac, (without arrhythmia detection)
Device brand name · Implantable cardiac monitor
Confirm: medical device reports filed with FDA
7,755 reports name it, 2009–2026. Manufacturer given most often on reports: St Jude Medical Crm-Sylmar. Product code MXC.
- 7,755
- device reports naming the brand
- 0% of all MAUDE reports · about 456 a year
- 34
- reports, 12 months to August 2026
- 89 in the 12 months before
- 85.8%
- classified as malfunction
- 85.7% across the product code
- 0.1%
- classified as death, as reported
- 5 reports · not verified by FDA
FDA's MAUDE database holds 7,755 reports that name the brand "Confirm" (implantable cardiac monitor), received between July 2009 and August 2026; the manufacturer given most often on reports is St Jude Medical Crm-Sylmar. Spellings of one product vary from report to report.
34 reports arrived in the 12 months to August 2026, down 62% from 89 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 (85.8%), injury (14.1%) and death (0.1%); across all recorder, event, implantable cardiac, (without arrhythmia detection) reports (product code MXC) death is recorded in 0.2% and malfunction in 85.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are under-sensing (45%), over-sensing (11.2%) and failure to interrogate (10%). The patient problems coded most often are pocket erosion, discomfort and no patient involvement. 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 11,316 reports carrying product code MXC. 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 |
|---|---|---|---|
| Under-sensing | 3,487 | 45% | 40.4% |
| Over-sensing | 869 | 11.2% | 11.8% |
| Failure to interrogate | 777 | 10% | 14.7% |
| Data problem | 399 | 5.1% | 4.2% |
| Pacemaker found in back-up mode | 299 | 3.9% | 2.7% |
| Signal artifact/noise | 299 | 3.9% | 3.6% |
| Premature discharge of battery | 280 | 3.6% | 5.6% |
| Device displays incorrect message | 246 | 3.2% | 2.2% |
| Failure to sense | 197 | 2.5% | 2.4% |
| Incorrect measurementthe device measured wrongly | 159 | 2.1% | 3.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 154 | 2% | 1.4% |
| Device sensing problem | 129 | 1.7% | 1.6% |
| Sensing intermittently | 128 | 1.7% | 1.3% |
| Inappropriate or unexpected reset | 126 | 1.6% | 2.2% |
| Wireless communication problema wireless connection problem | 102 | 1.3% | 1.3% |
| Incorrect interpretation of signal | 101 | 1.3% | 1.1% |
| Incorrect, inadequate or imprecise result or readings | 101 | 1.3% | 1.6% |
| Communication or transmission problemthe device could not communicate or transmit | 97 | 1.3% | 0.9% |
| Migration or expulsion of device | 77 | 1% | 1.1% |
| Difficult to interrogate | 59 | 0.8% | 0.5% |
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 |
|---|---|---|
| Pocket erosion | 118 | 1.5% |
| Discomfortdiscomfort | 84 | 1.1% |
| No patient involvement | 80 | 1% |
| Erosion | 62 | 0.8% |
| Wound dehiscencea wound reopened | 33 | 0.4% |
| Syncopefainting | 30 | 0.4% |
| Painpain, site not specified | 23 | 0.3% |
| Cardiac arrestthe heart stopped | 22 | 0.3% |
| Hematomaa collection of blood under the skin or in tissue | 13 | 0.2% |
| Twiddlers syndrome | 11 | 0.1% |
| Complaint, ill-defined | 10 | 0.1% |
| Dizzinesslight-headedness or unsteadiness | 9 | 0.1% |
| Bradycardiaslow heart rate | 8 | 0.1% |
| Arrhythmia | 4 | 0.1% |
| Atrial fibrillationan irregular heart rhythm | 4 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Confirm | Product code MXC | All MAUDE reports |
|---|---|---|---|
| Reports | 7,755 | 11,316 | 26,136,888 |
| Share of that pool | — | 68.5% | 0% |
| Classified as death, per 1,000 reports | 1 | 2 | 9 |
| Classified as injury | 14.1% | 14.1% | 36.2% |
| Classified as malfunction | 85.8% | 85.7% | 62.3% |
| Filed by the manufacturer | 100% | 99.8% | 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 MXC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Assert-IQ ICM | 2,350 | 1,162 | 0% |
| Jot Dx ICM | 1,071 | 139 | 0.1% |
| LUX-Dx Insertable Cardiac Monitor | 660 | 83 | 0% |
| Diamondback 360 Coronary Orbital Atherectomy System | 1,512 | 0 | 15.7% |
| Reveal LINQ | 19,184 | 264 | 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 Confirm reports
How many FDA reports name Confirm?
7,755 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 34 in the latest 12 months.
What kinds of events are reported?
malfunction (85.8%), injury (14.1%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
under-sensing (45%), over-sensing (11.2%), failure to interrogate (10%), data problem (5.1%) and pacemaker found in back-up mode (3.9%). 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 Confirm 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.