Recorder, event, implantable cardiac, (without arrhythmia detection): medical device reports filed with FDA

11,316 reports carry this product code, 2001–2026; 6 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

11,316
reports with this product code: 0% of all MAUDE reports; 1,347
reports, 12 months to August 2026: 1,057 in the 12 months before; 85.7%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code MXC is FDA's classification for "Recorder, event, implantable cardiac, (without arrhythmia detection)" (cardiovascular panel), a class 2 device. 11,316 medical device reports carry this product code, 0% of the MAUDE database, from May 2001 to August 2026.

1,347 reports arrived in the 12 months to August 2026, up 27% from 1,057 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 (85.7%), injury (14.1%) and death (0.2%). 6 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Confirm	7,752	34	0.1%	85.8%
Assert-IQ ICM	2,350	1,162	0%	88.7%
Jot Dx ICM	1,071	139	0.1%	84.3%
LUX-Dx Insertable Cardiac Monitor	2	83	0%	10.2%
Diamondback 360 Coronary Orbital Atherectomy System	1	0	15.7%	8.1%
Reveal LINQ	1	264	0%	93.6%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
St Jude Medical Crm-Sylmar	6,309	55.8%
Abbott	1,564	13.8%
St Jude Medical Crm-Sunnyvale	1,006	8.9%
Abbott Medical Crm-Sylmar	593	5.2%
St Jude Medical Crmd	584	5.2%
St Jude Medical	571	5%
St Jude Medical Cardiac Rhythm Management Division	197	1.7%
St Jude Medical Crm-Kista	83	0.7%
St Jude Medical Cardiac Rhythm Management Divisi	76	0.7%
Medtronic Med Rel	14	0.1%
Covidien Medical Products	3	0%
Cardiovascular Systems	1	0%
Medtronic Puerto Rico Operations Juncos	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.2%19

Injury14.1%1,595

Malfunction85.7%9,699

Other0%1

Not given0%2

Who filed

Manufacturer report99.8%11,290

Voluntary report0.2%20

User facility report0%0

Distributor report0%0

Not given0.1%6

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Under-sensing	4,576	40.4%
Failure to interrogate	1,659	14.7%
Over-sensing	1,333	11.8%
Premature discharge of battery	637	5.6%
Data problem	479	4.2%
Incorrect measurementthe device measured wrongly	410	3.6%
Signal artifact/noise	405	3.6%
Pacemaker found in back-up mode	300	2.7%
Failure to sense	269	2.4%
Device displays incorrect message	247	2.2%
Inappropriate or unexpected reset	244	2.2%
Device sensing problem	180	1.6%
Incorrect, inadequate or imprecise result or readings	179	1.6%
Interrogation problem	175	1.5%
Device operates differently than expectedthe device behaved unexpectedly	161	1.4%
Wireless communication problema wireless connection problem	148	1.3%
Sensing intermittently	144	1.3%
Incorrect interpretation of signal	130	1.1%
Migration or expulsion of device	125	1.1%
Communication or transmission problemthe device could not communicate or transmit	100	0.9%

Questions about recorder, event, implantable cardiac, (without arrhythmia detection) reports

What is product code MXC?

FDA's classification code for "Recorder, event, implantable cardiac, (without arrhythmia detection)", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

11,316 reports through August 2026, 1,347 of them in the latest 12 months.

Which brands appear most often?

Confirm (7,752), Assert-IQ ICM (2,350), Jot Dx ICM (1,071), LUX-Dx Insertable Cardiac Monitor (2) and Diamondback 360 Coronary Orbital Atherectomy System (1). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.