Leadless pacemaker: medical device reports filed with FDA

20,451 reports carry this product code, 2016–2026; 9 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.

20,451
reports with this product code: 0.1% of all MAUDE reports; 5,433
reports, 12 months to August 2026: 4,101 in the 12 months before; 54.6%
classified as malfunction: 62.3% across all reports; 6.3%
classified as death, as reported: 0.9% across all reports

Product code PNJ is FDA's classification for "Leadless pacemaker" (cardiovascular panel), a class 3 device. 20,451 medical device reports carry this product code, 0.1% of the MAUDE database, from June 2016 to August 2026.

5,433 reports arrived in the 12 months to August 2026, up 32% from 4,101 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 (54.6%), injury (39.1%) and death (6.3%). 9 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
Micra	5,972	524	8.4%	48.6%
Micra AV	4,223	277	7.9%	48.6%
Aveir Leadless Pacemaker, Right Ventricle	3,294	1,372	3.9%	67.9%
Micra AV2	3,070	1,502	5.7%	54.8%
Aveir Leadless Pacemaker, Right Atrium	1,352	523	1.4%	68.8%
Micra VR2	901	425	5.2%	61.4%
Aveir Delivery Catheter	867	433	11.8%	33.3%
AVEIR AR 2 Leadless Pacemaker	519	519	1.3%	65.5%
Pacemaker	2	15	5.9%	18.1%

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
Medtronic Ireland	14,005	68.5%
St Jude Medical Crm-Sylmar	3,872	18.9%
Abbott Medical Crm-Sylmar	1,481	7.2%
Abbott	692	3.4%
Medtronic Europe Sarl	6	0%
Medtronic Vascular	2	0%
Medtronic Cryocath	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

Death6.3%1,282

Injury39.1%7,998

Malfunction54.6%11,169

Other0%1

Not given0%1

Who filed

Manufacturer report99.4%20,322

Voluntary report0.4%85

User facility report0%0

Distributor report0%0

Not given0.2%44

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

Device problems coded

Device problem (FDA code)	Reports	Share
High capture threshold	3,657	17.9%
Failure to capture	2,630	12.9%
Capturing problem	2,485	12.2%
Device dislodged or dislocated	2,405	11.8%
Positioning problem	1,870	9.1%
Pacing problem	1,854	9.1%
Stretched	1,107	5.4%
Under-sensing	913	4.5%
Premature discharge of battery	808	4%
Material integrity problema problem with the device material	779	3.8%
Device sensing problem	639	3.1%
Failure to interrogate	591	2.9%
Premature separation	568	2.8%
Mechanical problema mechanical problem	563	2.8%
Low impedance	501	2.4%
Impedance problem	468	2.3%
Activation, positioning or separation problem	467	2.3%
High impedance	463	2.3%
Separation failure	462	2.3%
Intermittent capture	457	2.2%

Questions about leadless pacemaker reports

What is product code PNJ?

FDA's classification code for "Leadless pacemaker", class 3, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

20,451 reports through August 2026, 5,433 of them in the latest 12 months.

Which brands appear most often?

Micra (5,972), Micra AV (4,223), Aveir Leadless Pacemaker, Right Ventricle (3,294), Micra AV2 (3,070) and Aveir Leadless Pacemaker, Right Atrium (1,352). 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.