Recorder, event, implantable cardiac, (with arrhythmia detection): medical device reports filed with FDA

12,977 reports carry this product code, 2001–2026; 3 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.

12,977
reports with this product code: 0.1% of all MAUDE reports; 3,508
reports, 12 months to August 2026: 3,246 in the 12 months before; 82.8%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code MXD is FDA's classification for "Recorder, event, implantable cardiac, (with arrhythmia detection)" (cardiovascular panel), a class 2 device. 12,977 medical device reports carry this product code, 0.1% of the MAUDE database, from November 2001 to August 2026.

3,508 reports arrived in the 12 months to August 2026, close to the 3,246 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 malfunction (82.8%) and injury (17.2%). 3 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
LUX-Dx Insertable Cardiac Monitor	657	83	0%	10.2%
BIOMONITOR IIIm	435	66	0%	39.1%
Biomonitor 2-Af	231	0	0.4%	32.9%

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
Medtronic Singapore Operations	10,170	78.4%
Biotronik Se & Kg	1,486	11.5%
Biotronik	4	0%
Bard	1	0%
Cardiac Pacemakers	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%4

Injury17.2%2,233

Malfunction82.8%10,739

Other0%1

Not given0%0

Who filed

Manufacturer report99.6%12,930

Voluntary report0.3%33

User facility report0%0

Distributor report0%0

Not given0.1%14

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

Device problems coded

Device problem (FDA code)	Reports	Share
Reset problem	2,501	19.3%
Premature discharge of battery	1,924	14.8%
Output problem	1,276	9.8%
Inappropriate or unexpected reset	1,264	9.7%
Signal artifact/noise	1,106	8.5%
Under-sensing	991	7.6%
Over-sensing	769	5.9%
Device sensing problem	691	5.3%
Data problem	689	5.3%
Migration or expulsion of device	652	5%
Communication or transmission problemthe device could not communicate or transmit	409	3.2%
Battery problema problem with the battery	345	2.7%
Electromagnetic interference	246	1.9%
Failure to interrogate	216	1.7%
Unable to obtain readings	206	1.6%
Mechanical problema mechanical problem	122	0.9%
Premature elective replacement indicator	89	0.7%
Ambient noise problem	78	0.6%
Migrationthe device moved from where it was placed	74	0.6%
Decreased sensitivity	73	0.6%

Questions about recorder, event, implantable cardiac, (with arrhythmia detection) reports

What is product code MXD?

FDA's classification code for "Recorder, event, implantable cardiac, (with 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?

12,977 reports through August 2026, 3,508 of them in the latest 12 months.

Which brands appear most often?

LUX-Dx Insertable Cardiac Monitor (657), BIOMONITOR IIIm (435) and Biomonitor 2-Af (231). 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.