Leadless Pacemaker
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class III (highest risk, premarket approval required), regulated under 21 CFR §870.3610 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Leadless Pacemaker MID-BOOK · MAUDE
#142 of 1000 · 19,964 reports · 2016–2026
- BOOK 19,964 reports
- RANK #142 of 1000
- DEATH 1,257 death-typed
- INJ 7,807 injury-typed
- MALF 10,899 malfunction
- SPAN 2016–2026
- PEAK 2025: 4,435
- PHOTO Suture
Nearest event-volume peer: Suture, Nonabsorbable, Synthetic, Polyethylene (46 report gap)
Leadless Pacemaker sits #142 of 1000 among tracked device types with 19,964 MAUDE reports spanning 2016–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports sit below the device-type norm
Leadless Pacemaker carries 54.6% MALFUNCTION-coded reports, 10.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 6.3% corpus 1.5% · above corpus mean (+4.8 pp)
- INJ 39.1% corpus 30.3% · above corpus mean (+8.8 pp)
- MALF 54.6% corpus 64.8% · below corpus mean (-10.2 pp)
Lead product-problem code High Capture Threshold is 13% of coded problems · Lead manufacturer MEDTRONIC IRELAND accounts for 69% of manufacturer-tagged reports · Top event location is 80% of location-tagged rows .
Leadless Pacemaker in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Reagents
Reagents, 2019-Novel Coronavirus Nucleic Acid
20,142 reports
- Catheter
Catheter, Intravascular, Diagnostic
20,128 reports
- Suture
Suture, Nonabsorbable, Synthetic, Polyethylene
20,010 reports
- Leadless Pace… (this)
Leadless Pacemaker
19,964 reports
- Dorsal Root G…
Dorsal Root Ganglion Stimulator For Pain Relief
19,735 reports
- Suture
Suture, Nonabsorbable, Synthetic, Polypropylene
19,686 reports
What this shows Leadless Pacemaker carries 19,964 MAUDE reports, ranked #142 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 4,435 in 2025, up from an average of 3,009 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Leadless Pacemaker
Top Manufacturers
Event Locations
Compare MEDTRONIC IRELAND vs ST. JUDE MEDICAL, INC.(CRM-SYLMAR) →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Leadless Pacemaker: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (19,964 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1,257 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Leadless Pacemaker are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Leadless Pacemaker; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.