Device brand name · Leadless pacemaker
AVEIR AR 2 Leadless Pacemaker: medical device reports filed with FDA
519 reports name it, 2025–2026. Manufacturer given most often on reports: Abbott Medical Crm-Sylmar. Product code PNJ.
- 519
- device reports naming the brand
- 0% of all MAUDE reports · about 519 a year
- 519
- reports, 12 months to August 2026
- 0 in the 12 months before
- 65.5%
- classified as malfunction
- 54.6% across the product code
- 1.3%
- classified as death, as reported
- 7 reports · not verified by FDA
FDA's MAUDE database holds 519 reports that name the brand "AVEIR AR 2 Leadless Pacemaker" (leadless pacemaker), received between September 2025 and August 2026; the manufacturer given most often on reports is Abbott Medical Crm-Sylmar. Spellings of one product vary from report to report.
519 reports arrived in the 12 months to August 2026, with none 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 (65.5%), injury (33.1%) and death (1.3%); across all leadless pacemaker reports (product code PNJ) death is recorded in 6.3% and malfunction in 54.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device dislodged or dislocated (26.2%), stretched (17.1%) and failure to capture (15.4%). The patient problems coded most often are embolism/embolus, pericardial effusion and cardiac perforation. 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.
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 20,451 reports carrying product code PNJ. 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 |
|---|---|---|---|
| Device dislodged or dislocated | 136 | 26.2% | 11.8% |
| Stretched | 89 | 17.1% | 5.4% |
| Failure to capture | 80 | 15.4% | 12.9% |
| Separation failure | 70 | 13.5% | 2.3% |
| Premature separation | 43 | 8.3% | 2.8% |
| Positioning failure | 37 | 7.1% | 1.5% |
| Connection problema connection problem | 35 | 6.7% | 1.7% |
| Capturing problem | 33 | 6.4% | 12.2% |
| Low impedance | 30 | 5.8% | 2.4% |
| Device sensing problem | 29 | 5.6% | 3.1% |
| Failure to interrogate | 29 | 5.6% | 2.9% |
| Failure to sense | 24 | 4.6% | 0.6% |
| Over-sensing | 22 | 4.2% | 1.6% |
| Inappropriate or unexpected reset | 15 | 2.9% | 1.5% |
| Difficult or delayed separation | 12 | 2.3% | 0.7% |
| Interrogation problem | 12 | 2.3% | 0.8% |
| Under-sensing | 11 | 2.1% | 4.5% |
| Incorrect measurementthe device measured wrongly | 10 | 1.9% | 0.9% |
| Pacing problem | 10 | 1.9% | 9.1% |
| Therapy delivered to incorrect body area | 10 | 1.9% | 0.2% |
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 |
|---|---|---|
| Embolism/embolus | 127 | 24.5% |
| Pericardial effusionfluid around the heart | 45 | 8.7% |
| Cardiac perforation | 42 | 8.1% |
| Arrhythmia | 34 | 6.6% |
| Discomfortdiscomfort | 26 | 5% |
| Low blood pressure/ hypotension | 22 | 4.2% |
| Cardiac tamponade | 17 | 3.3% |
| Thrombosis/thrombus | 7 | 1.3% |
| Syncope/fainting | 3 | 0.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.4% |
| Dyspneashortness of breath | 2 | 0.4% |
| Dizzinesslight-headedness or unsteadiness | 1 | 0.2% |
| Fever | 1 | 0.2% |
| Heart failure/congestive heart failure | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | AVEIR AR 2 Leadless Pacemaker | Product code PNJ | All MAUDE reports |
|---|---|---|---|
| Reports | 519 | 20,451 | 26,136,888 |
| Share of that pool | — | 2.5% | 0% |
| Classified as death, per 1,000 reports | 13 | 63 | 9 |
| Classified as injury | 33.1% | 39.1% | 36.2% |
| Classified as malfunction | 65.5% | 54.6% | 62.3% |
| Filed by the manufacturer | 100% | 99.4% | 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 PNJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Micra | 7,144 | 524 | 8.4% |
| Micra AV | 4,223 | 277 | 7.9% |
| Aveir Leadless Pacemaker, Right Ventricle | 3,294 | 1,372 | 3.9% |
| Micra AV2 | 3,070 | 1,502 | 5.7% |
| Aveir Leadless Pacemaker, Right Atrium | 1,352 | 523 | 1.4% |
| Micra VR2 | 901 | 425 | 5.2% |
| Aveir Delivery Catheter | 867 | 433 | 11.8% |
| Pacemaker | 221 | 15 | 5.9% |
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." 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 AVEIR AR 2 Leadless Pacemaker reports
How many FDA reports name AVEIR AR 2 Leadless Pacemaker?
519 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 519 in the latest 12 months.
What kinds of events are reported?
malfunction (65.5%), injury (33.1%) and death (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (26.2%), stretched (17.1%), failure to capture (15.4%), separation failure (13.5%) and premature separation (8.3%). 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 AVEIR AR 2 Leadless Pacemaker 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.