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 MAUDE casebook
openFDA event book Leadless Pacemaker MID-BOOK · MAUDE
#149 of 1000 · 17,499 reports · 2016–2026
- BOOK 17,499 reports
- RANK #149 of 1000
- DEATH 1,149 death-typed
- INJ 6,912 injury-typed
- MALF 9,437 malfunction
- SPAN 2016–2026
- PEAK 2025: 4,435
- PHOTO Phakic Toric Intraocu…
Nearest event-volume peer: Phakic Toric Intraocular Lens (0 report gap)
Leadless Pacemaker sits #149 of 1000 among tracked device types with 17,499 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 →
Event-type mix vs corpus
Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.
- DEATH 6.6% corpus 1.5% · above corpus mean (+5.0 pp)
- INJ 39.5% corpus 30.4% · above corpus mean (+9.1 pp)
- MALF 53.9% corpus 64.5% · below corpus mean (-10.6 pp)
Lead product-problem code High Capture Threshold is 13% of coded problems · Lead manufacturer MEDTRONIC IRELAND accounts for 73% of manufacturer-tagged reports · Top event location is 77% of location-tagged rows .
Leadless Pacemaker in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Immunoassay M…
Immunoassay Method, Troponin Subunit
17,726 reports
- Implant
Implant, Intragastric For Morbid Obesity
17,588 reports
- General Surge…
General Surgery Tray
17,567 reports
- Device
Device, Incontinence, Mechanical/Hydraulic
17,504 reports
- Leadless Pace… (this)
Leadless Pacemaker
17,499 reports
- Phakic Toric…
Phakic Toric Intraocular Lens
17,499 reports
What this shows Leadless Pacemaker carries 17,499 MAUDE reports, ranked #149 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
Related Entities for Leadless Pacemaker
Top Manufacturers
Event Locations
Compare MEDTRONIC IRELAND vs ST. JUDE MEDICAL, INC.(CRM-SYLMAR) →
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Leadless Pacemaker, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (17,499 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1,149 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.