Defibrillator, implantable, dual-chamber: medical device reports filed with FDA

7,873 reports carry this product code, 2001–2026; 21 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.

7,873
reports with this product code: 0% of all MAUDE reports; 443
reports, 12 months to August 2026: 453 in the 12 months before; 60%
classified as malfunction: 62.3% across all reports; 2.4%
classified as death, as reported: 0.9% across all reports

Product code MRM is FDA's classification for "Defibrillator, implantable, dual-chamber" (unknown panel), a class 3 device. 7,873 medical device reports carry this product code, 0% of the MAUDE database, from June 2001 to August 2026.

443 reports arrived in the 12 months to August 2026, close to the 453 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 (60%), injury (36.1%) and death (2.4%). 21 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
Paradym	826	0	1.9%	61.7%
Isoline	563	6	0.8%	25.8%
Ovatio	548	0	3.3%	47.4%
Platinium	499	42	1.2%	72.7%
Alto	190	60	3.5%	9.7%
Orchestra	130	0	0.1%	99%
Lumax 340 Hf-T	119	0	9.7%	39.8%
Paradym Rf	106	0	1.7%	59.3%
Lumax 540 Hf-T	100	0	10.5%	52.7%
SmartTouch	42	132	0%	100%
Lumax 340 Vr-T	41	0	5.2%	59%
Smartview	31	5	0%	99.7%
Lumax 540 Vr-T	23	0	3.5%	79.6%
Kora	3	21	0%	98.9%
Linox SD 65/16	3	31	1.2%	66.3%
Linox Smart S 65	2	26	0.7%	66.8%
Corox Otw 85-Bp	1	0	0.5%	43.5%
Corox OTW-L 85-BP	1	5	1.1%	43.1%
Pacemaker	1	15	5.9%	18.1%
Setrox S 53	1	128	1.2%	47.5%
Tendril Sdx	1	3	2.3%	36.1%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Biotronik Se & Kg	4,151	52.7%
Sorin Group Italia - Crm Facility	1,244	15.8%
Sorin Crm	675	8.6%
Microport Crm	376	4.8%
Ela Medical	329	4.2%
Biotronik And	151	1.9%
Biotronik	148	1.9%
Sorin Group Italia	135	1.7%

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

Death2.4%191

Injury36.1%2,839

Malfunction60%4,725

Other1.4%108

Not given0.1%10

Who filed

Manufacturer report98.6%7,765

Voluntary report1.2%96

User facility report0%0

Distributor report0%0

Not given0.2%12

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

Device problems coded

Device problem (FDA code)	Reports	Share
Premature elective replacement indicator	1,609	20.4%
Over-sensing	954	12.1%
Premature end-of-life indicator	695	8.8%
Inappropriate/inadequate shock/stimulation	563	7.2%
Failure to interrogate	463	5.9%
Explanted	347	4.4%
High impedance	225	2.9%
Premature discharge of battery	218	2.8%
Device displays incorrect message	199	2.5%
Insufficient device problem information	180	2.3%
Battery problema problem with the battery	172	2.2%
Low impedance	149	1.9%
Device operates differently than expectedthe device behaved unexpectedly	147	1.9%
Device remains implanted	138	1.8%
Pacemaker found in back-up mode	134	1.7%
Normal	126	1.6%
Display or visual feedback problem	111	1.4%
Ambient noise problem	106	1.3%
Defibrillation/stimulation problem	98	1.2%
Connection problema connection problem	97	1.2%

Questions about defibrillator, implantable, dual-chamber reports

What is product code MRM?

FDA's classification code for "Defibrillator, implantable, dual-chamber", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

7,873 reports through August 2026, 443 of them in the latest 12 months.

Which brands appear most often?

Paradym (826), Isoline (563), Ovatio (548), Platinium (499) and Alto (190). 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.