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2026 data FDA MAUDE openFDA FDA Class III

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

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 Right Ventricular Or… HEAVY-BOOK · MAUDE

#19 of 1000 · 228,094 reports · 1997–2026

  • BOOK 228,094 reports
  • RANK #19 of 1000
  • DEATH 5,055 death-typed
  • INJ 128,126 injury-typed
  • MALF 94,775 malfunction
  • SPAN 1997–2026
  • PEAK 2023: 24,991
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled (1,084 report gap)

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes sits #19 of 1000 among tracked device types with 228,094 MAUDE reports spanning 1997–2026. 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 Right Ventricular Or… 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 2.2% corpus 1.5% · above corpus mean (+0.7 pp)
  • INJ 56.2% corpus 30.3% · above corpus mean (+25.9 pp)
  • MALF 41.6% corpus 64.8% · below corpus mean (-23.3 pp)

Lead product-problem code Over-Sensing is 13% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC.(CRM-SYLMAR) accounts for 32% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Drug Eluting Permanent Right Ventricular Or… in the event-volume neighbourhood

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

reports

What this shows Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes carries 228,094 MAUDE reports, ranked #19 of 1000.

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

Event Types

Injury 128,126 (56.2%)
Malfunction 94,775 (41.6%)
Death 5,055 (2.2%)
99 (0.0%)
Other 39 (0.0%)

Patient Outcomes

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

82,130 (28.0%)
Required Intervention 70,117 (23.9%)
Hospitalization 62,397 (21.2%)
R 41,345 (14.1%)
H 14,165 (4.8%)
L 11,619 (4.0%)
Death 4,969 (1.7%)
Other 3,372 (1.1%)
Life Threatening 2,811 (1.0%)
O 690 (0.2%)
D 86 (0.0%)
S 47 (0.0%)
Congenital Anomaly 37 (0.0%)
Disability 24 (0.0%)
C 1 (0.0%)

Top Product Problems

Over-Sensing 40,913
Adverse Event Without Identified Device or Use Problem 40,290
Device Dislodged or Dislocated 35,954
Failure to Capture 28,775
High Capture Threshold 24,419
High impedance 20,806
Signal Artifact/Noise 20,563
Break 11,846
Low impedance 11,597
Fracture 10,720
Capturing Problem 10,645
Under-Sensing 10,300
Pacing Problem 9,975
Device Sensing Problem 8,492
Insufficient Device Problem Information 5,819
Impedance Problem 4,989
Material Integrity Problem 4,940
Failure to Sense 4,687
Defective Device 3,814
Appropriate Device Problem Term/Code Not Available 3,758

Yearly Trend

97
1997: 1
98
1998: 1
03
2003: 1
04
2004: 2
06
2006: 26
07
2007: 46
08
2008: 64
09
2009: 85
10
2010: 1,853
11
2011: 6,197
12
2012: 5,888
13
2013: 7,653
14
2014: 9,886
15
2015: 10,137
16
2016: 9,393
17
2017: 11,613
18
2018: 11,519
19
2019: 16,873
20
2020: 16,529
21
2021: 17,757
22
2022: 18,200
23
2023: 24,991
24
2024: 22,014
25
2025: 23,656
26
2026: 13,709

Reports in 2025 (23,656) held close to the prior two-year average of 23,503.

Related Entities for Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Top Manufacturers

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 66,520
BOSTON SCIENTIFIC CORPORATION 36,525
MPRI 28,483
BIOTRONIK SE & CO. KG 26,435
CPI - DEL CARIBE 12,034
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 9,582
ST. JUDE MEDICAL, INC., CRMD 8,145
ABBOTT 7,032
MEDTRONIC PUERTO RICO VILLALBA 5,760
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5,760

Event Locations

132,841 (58.2%)
I 85,190 (37.3%)
HOSPITAL 9,207 (4.0%)
OTHER 733 (0.3%)
NO INFORMATION 75 (0.0%)
OUTPATIENT TREATMENT FACILITY 36 (0.0%)
HOME 9 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
CLINIC - WALK IN, OTHER 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare ST. JUDE MEDICAL, INC.(CRM-SYLMAR) vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Drug Eluting Permanent Right Ventricular Or…: 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 (228,094 here).

Prosthesis 229,178 Ventilator, Continuous, Facility Use 212,024 Automated External Defibrillators 268,697 Sensor, Glucose, Invasive 281,941

Similar death-typed counts

Nearest other device types by death-typed report count (5,055 here), distinct from the volume row.

Defibrillator 4,802 Ventilator, Non-Continuous 4,569 Temporary Non-Roller Type Left Heart Suppor… 5,667 Pulse Generator, Permanent, Implantable 3,912

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

Disclaimer: MAUDE figures for Drug Eluting Permanent Right Ventricular Or… 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 Right Ventricular Or…; 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.