Device brand name · Leadless pacemaker
Micra AV2: medical device reports filed with FDA
3,070 reports name it, 2023–2026. Manufacturer given most often on reports: Medtronic Ireland. Product code PNJ.
- 3,070
- device reports naming the brand
- 0% of all MAUDE reports · about 997 a year
- 1,502
- reports, 12 months to August 2026
- 1,118 in the 12 months before
- 54.8%
- classified as malfunction
- 54.6% across the product code
- 5.7%
- classified as death, as reported
- 175 reports · not verified by FDA
FDA's MAUDE database holds 3,070 reports that name the brand "Micra AV2" (leadless pacemaker), received between June 2023 and August 2026; the manufacturer given most often on reports is Medtronic Ireland. Spellings of one product vary from report to report.
1,502 reports arrived in the 12 months to August 2026, up 34% from 1,118 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 (54.8%), injury (39.5%) and death (5.7%); 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 high capture threshold (28.4%), positioning problem (16.4%) and capturing problem (16.1%). The patient problems coded most often are pericardial effusion, cardiac perforation and cardiac tamponade. 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.
By year received
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 |
|---|---|---|---|
| High capture threshold | 873 | 28.4% | 17.9% |
| Positioning problem | 504 | 16.4% | 9.1% |
| Capturing problem | 493 | 16.1% | 12.2% |
| Failure to capture | 382 | 12.4% | 12.9% |
| Pacing problem | 356 | 11.6% | 9.1% |
| Device dislodged or dislocated | 302 | 9.8% | 11.8% |
| Material integrity problema problem with the device material | 228 | 7.4% | 3.8% |
| Mechanical problema mechanical problem | 176 | 5.7% | 2.8% |
| Data problem | 159 | 5.2% | 1.2% |
| Impedance problem | 141 | 4.6% | 2.3% |
| Under-sensing | 138 | 4.5% | 4.5% |
| Activation, positioning or separation problem | 120 | 3.9% | 2.3% |
| Unstable capture threshold | 115 | 3.7% | 2.1% |
| Intermittent capture | 107 | 3.5% | 2.2% |
| Leak/splashthe device leaked | 90 | 2.9% | 1.8% |
| Failure to interrogate | 81 | 2.6% | 2.9% |
| Decreased sensitivity | 72 | 2.3% | 2.1% |
| Device sensing problem | 70 | 2.3% | 3.1% |
| High impedance | 69 | 2.2% | 2.3% |
| Premature discharge of battery | 64 | 2.1% | 4% |
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 |
|---|---|---|
| Pericardial effusionfluid around the heart | 275 | 9% |
| Cardiac perforation | 233 | 7.6% |
| Cardiac tamponade | 204 | 6.6% |
| Bradycardiaslow heart rate | 148 | 4.8% |
| Low blood pressure/ hypotension | 110 | 3.6% |
| Cardiac arrestthe heart stopped | 70 | 2.3% |
| Dyspneashortness of breath | 70 | 2.3% |
| Dizzinesslight-headedness or unsteadiness | 62 | 2% |
| Arrhythmia | 61 | 2% |
| Syncope/fainting | 61 | 2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 53 | 1.7% |
| Discomfortdiscomfort | 42 | 1.4% |
| Tachycardiafast heart rate | 41 | 1.3% |
| Chest painchest pain | 38 | 1.2% |
| Asystole | 37 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Micra AV2 | Product code PNJ | All MAUDE reports |
|---|---|---|---|
| Reports | 3,070 | 20,451 | 26,136,888 |
| Share of that pool | — | 15% | 0% |
| Classified as death, per 1,000 reports | 57 | 63 | 9 |
| Classified as injury | 39.5% | 39.1% | 36.2% |
| Classified as malfunction | 54.8% | 54.6% | 62.3% |
| Filed by the manufacturer | 99.8% | 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% |
| Aveir Leadless Pacemaker, Right Atrium | 1,352 | 523 | 1.4% |
| Micra VR2 | 901 | 425 | 5.2% |
| Aveir Delivery Catheter | 867 | 433 | 11.8% |
| AVEIR AR 2 Leadless Pacemaker | 519 | 519 | 1.3% |
| 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 Micra AV2 reports
How many FDA reports name Micra AV2?
3,070 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,502 in the latest 12 months.
What kinds of events are reported?
malfunction (54.8%), injury (39.5%) and death (5.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
high capture threshold (28.4%), positioning problem (16.4%), capturing problem (16.1%), failure to capture (12.4%) and pacing problem (11.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Micra AV2 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.