Permanent Pacemaker Electrode
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 §870.3680 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Permanent Pacemaker Electrode HEAVY-BOOK · MAUDE
#12 of 1000 · 325,343 reports · 1992–2026
- BOOK 325,343 reports
- RANK #12 of 1000
- DEATH 9,381 death-typed
- INJ 172,985 injury-typed
- MALF 142,375 malfunction
- SPAN 1992–2026
- PEAK 2023: 34,542
- PHOTO Sensor
Nearest event-volume peer: Sensor, Glucose, Invasive, Non-Adjunctive (628 report gap)
Permanent Pacemaker Electrode sits #12 of 1000 among tracked device types with 325,343 MAUDE reports spanning 1992–2026. 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 →
Injury-coded reports run above the device-type norm
Permanent Pacemaker Electrode carries 53.2% INJURY-coded reports, 22.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 2.9% corpus 1.5% · above corpus mean (+1.4 pp)
- INJ 53.2% corpus 30.3% · above corpus mean (+22.9 pp)
- MALF 43.8% corpus 64.8% · below corpus mean (-21.1 pp)
Lead product-problem code Under-Sensing is 13% of coded problems · Lead manufacturer MPRI accounts for 52% of manufacturer-tagged reports · Top event location is 47% of location-tagged rows .
Permanent Pacemaker Electrode in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Stimulator
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
375,710 reports
- Permanent Pac… (this)
Permanent Pacemaker Electrode
325,343 reports
- Sensor
Sensor, Glucose, Invasive, Non-Adjunctive
324,715 reports
- Set
Set, Administration, Intravascular
309,977 reports
- Ventilator
Ventilator, Non-Continuous (Respirator)
300,898 reports
- Sensor
Sensor, Glucose, Invasive
281,941 reports
What this shows Permanent Pacemaker Electrode carries 325,343 MAUDE reports, ranked #12 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 in 2025 (25,912) held close to the prior two-year average of 30,116.
Related Entities for Permanent Pacemaker Electrode
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Permanent Pacemaker Electrode: 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 (325,343 here).
Similar death-typed counts
Nearest other device types by death-typed report count (9,381 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Permanent Pacemaker Electrode 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 Permanent Pacemaker Electrode; 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.