2026 data FDA MAUDE openFDA FDA Class III

Drug Eluting Permanent Left Ventricular (Lv) 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 MAUDE casebook

openFDA event book Drug Eluting Permanent Left Ventricular Pac… MID-BOOK · MAUDE

#68 of 1000 · 52,206 reports · 2005–2026

  • BOOK 52,206 reports
  • RANK #68 of 1000
  • DEATH 1,856 death-typed
  • INJ 29,356 injury-typed
  • MALF 20,961 malfunction
  • SPAN 2005–2026
  • PEAK 2023: 4,468
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Autonomic Nerve, Implanted For Epilepsy (308 report gap)

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode sits #68 of 1000 among tracked device types with 52,206 MAUDE reports spanning 2005–2026. 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

Drug Eluting Permanent Left Ventricular Pac… carries 56.2% INJURY-coded reports, 25.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.6% corpus 1.5% · above corpus mean (+2.0 pp)
  • INJ 56.2% corpus 30.3% · above corpus mean (+25.9 pp)
  • MALF 40.2% corpus 64.8% · below corpus mean (-24.7 pp)

Lead product-problem code Device Dislodged or Dislocated is 19% of coded problems · Lead manufacturer MPRI accounts for 48% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Drug Eluting Permanent Left Ventricular Pac… in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode carries 52,206 MAUDE reports, ranked #68 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 29,356 (56.2%)
Malfunction 20,961 (40.2%)
Death 1,856 (3.6%)
26 (0.0%)
Other 7 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

17,617 (25.1%)
Hospitalization 16,000 (22.8%)
Required Intervention 13,940 (19.9%)
R 13,175 (18.8%)
H 2,600 (3.7%)
L 2,262 (3.2%)
Death 1,819 (2.6%)
Other 1,778 (2.5%)
Life Threatening 771 (1.1%)
O 158 (0.2%)
D 29 (0.0%)
S 7 (0.0%)
Congenital Anomaly 3 (0.0%)
Disability 3 (0.0%)

Top Product Problems

Device Dislodged or Dislocated 12,322
Adverse Event Without Identified Device or Use Problem 11,919
High Capture Threshold 8,259
Failure to Capture 8,149
High impedance 4,502
Appropriate Device Problem Term/Code Not Available 2,993
Capturing Problem 2,795
Activation, Positioning or Separation Problem 1,573
Fracture 1,549
Positioning Problem 1,494
Impedance Problem 1,262
Low impedance 1,215
Break 1,204
Insufficient Device Problem Information 1,161
Extracardiac stimulation 760
Unstable Capture Threshold 687
Difficult To Position 678
Difficult to Insert 570
Intermittent Capture 556
Pacing Problem 532

Yearly Trend

05
2005: 1
06
2006: 1
07
2007: 5
08
2008: 5
09
2009: 66
10
2010: 1,437
11
2011: 3,030
12
2012: 2,417
13
2013: 2,482
14
2014: 3,002
15
2015: 3,724
16
2016: 3,030
17
2017: 3,293
18
2018: 3,978
19
2019: 3,926
20
2020: 2,776
21
2021: 2,869
22
2022: 2,947
23
2023: 4,468
24
2024: 3,396
25
2025: 3,420
26
2026: 1,933

Reports in 2025 (3,420) held close to the prior two-year average of 3,932.

Related Entities for Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Event Locations

26,475 (50.7%)
I 21,633 (41.4%)
HOSPITAL 3,919 (7.5%)
NO INFORMATION 85 (0.2%)
OTHER 71 (0.1%)
OUTPATIENT TREATMENT FACILITY 19 (0.0%)
HOME 3 (0.0%)
NOT APPLICABLE 1 (0.0%)

Compare MPRI vs ST. JUDE MEDICAL, INC.(CRM-SYLMAR) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Drug Eluting Permanent Left Ventricular Pac…: 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 (52,206 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1,856 here), distinct from the volume row.

Disclaimer: MAUDE figures for Drug Eluting Permanent Left Ventricular Pac… 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 Drug Eluting Permanent Left Ventricular Pac…; 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.