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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#68 of 1000 · 50,826 reports · 2005–2026

  • BOOK 50,826 reports
  • RANK #68 of 1000
  • DEATH 1,840 death-typed
  • INJ 28,557 injury-typed
  • MALF 20,396 malfunction
  • SPAN 2005–2026
  • PEAK 2023: 4,468
  • PHOTO Syringe, Piston

Nearest event-volume peer: Syringe, Piston (208 report gap)

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode sits #68 of 1000 among tracked device types with 50,826 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 →

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 3.6% corpus 1.5% · above corpus mean (+2.1 pp)
  • INJ 56.2% corpus 30.4% · above corpus mean (+25.7 pp)
  • MALF 40.1% corpus 64.5% · below corpus mean (-24.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 23% of coded problems · Lead manufacturer MPRI accounts for 49% of manufacturer-tagged reports · Top event location is 49% 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 50,826 MAUDE reports, ranked #68 of 1000.

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

Event Types

Injury 28,557 (56.2%)
Malfunction 20,396 (40.1%)
Death 1,840 (3.6%)
26 (0.1%)
Other 7 (0.0%)

Patient Outcomes

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

17,131 (25.0%)
Hospitalization 15,781 (23.0%)
Required Intervention 13,552 (19.8%)
R 12,955 (18.9%)
H 2,377 (3.5%)
L 2,245 (3.3%)
Death 1,805 (2.6%)
Other 1,761 (2.6%)
Life Threatening 753 (1.1%)
O 159 (0.2%)
D 29 (0.0%)
S 7 (0.0%)
Congenital Anomaly 3 (0.0%)
Disability 3 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 9,800
Device Dislodged or Dislocated 6,979
High Capture Threshold 6,412
Failure to Capture 4,890
High impedance 2,665
Capturing Problem 2,219
Activation, Positioning or Separation Problem 1,287
Appropriate Term/Code Not Available 1,214
Impedance Problem 1,058
Positioning Problem 969
Low impedance 906
Break 799
Fracture 712
Unstable Capture Threshold 545
Intermittent Capture 426
Insufficient Information 362
Difficult to Insert 356
Difficult to Remove 347
Over-Sensing 334
Pacing Problem 315

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: 553

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

Top Manufacturers

MPRI 23,186
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5,827
CPI - DEL CARIBE 4,344
BIOTRONIK SE & CO. KG 3,775
MEDTRONIC PUERTO RICO, INC. 2,964
ST. JUDE MEDICAL, INC., CRMD 1,977
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1,974
MEDTRONIC PUERTO RICO VILLALBA 1,696
ST. JUDE MEDICAL, INC. 866
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 679

Event Locations

25,083 (49.4%)
I 21,645 (42.6%)
HOSPITAL 3,919 (7.7%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Drug Eluting Permanent Left Ventricular Pac…, 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 (50,826 here).

Syringe, Piston 51,034 Stimulator 51,263 Stimulator 51,502 Instrument 49,230

Similar death-typed counts

Nearest other device types by death-typed report count (1,840 here), distinct from the volume row.

Monitor, Physiological, Patient 1,857 Implantable Pulse Generator, Pacemaker 1,816 Stimulator 1,806 Implantable Pacemaker Pulse-Generator 1,915

Read our methodology - how this data is sourced, computed, and verified.

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.