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2026 data FDA MAUDE openFDA

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

#17 of 1000 · 218,060 reports · 1997–2026

  • BOOK 218,060 reports
  • RANK #17 of 1000
  • DEATH 4,956 death-typed
  • INJ 122,406 injury-typed
  • MALF 90,562 malfunction
  • SPAN 1997–2026
  • PEAK 2023: 24,991
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled (3,246 report gap)

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes sits #17 of 1000 among tracked device types with 218,060 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 →

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 2.3% corpus 1.5% · above corpus mean (+0.8 pp)
  • INJ 56.1% corpus 30.4% · above corpus mean (+25.7 pp)
  • MALF 41.5% corpus 64.5% · below corpus mean (-23.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 14% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC.(CRM-SYLMAR) accounts for 33% of manufacturer-tagged reports · Top event location is 56% 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 218,060 MAUDE reports, ranked #17 of 1000.

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

Event Types

Injury 122,406 (56.1%)
Malfunction 90,562 (41.5%)
Death 4,956 (2.3%)
99 (0.0%)
Other 37 (0.0%)

Patient Outcomes

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

78,675 (27.8%)
Required Intervention 67,150 (23.8%)
Hospitalization 60,979 (21.6%)
R 39,895 (14.1%)
H 12,702 (4.5%)
L 11,535 (4.1%)
Death 4,875 (1.7%)
Other 3,278 (1.2%)
Life Threatening 2,735 (1.0%)
O 662 (0.2%)
D 79 (0.0%)
S 47 (0.0%)
Congenital Anomaly 36 (0.0%)
Disability 24 (0.0%)
C 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 34,393
Over-Sensing 32,367
Device Dislodged or Dislocated 26,100
Failure to Capture 20,653
High Capture Threshold 19,751
Signal Artifact/Noise 19,620
High impedance 15,382
Break 9,656
Capturing Problem 8,956
Low impedance 8,562
Pacing Problem 8,302
Under-Sensing 8,269
Fracture 7,122
Device Sensing Problem 5,504
Impedance Problem 3,904
Defective Device 3,768
Material Integrity Problem 3,528
Insufficient Information 3,447
Failure to Sense 3,382
Positioning Problem 3,060

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: 6,196
12
2012: 5,889
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: 22,013
25
2025: 23,659
26
2026: 3,673

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

Top Manufacturers

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 66,064
BOSTON SCIENTIFIC CORPORATION 33,643
MPRI 28,488
BIOTRONIK SE & CO. KG 25,615
CPI - DEL CARIBE 12,035
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 9,582
ST. JUDE MEDICAL, INC., CRMD 8,145
ABBOTT 6,837
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5,760
MEDTRONIC PUERTO RICO VILLALBA 3,505

Event Locations

122,770 (56.3%)
I 85,234 (39.1%)
HOSPITAL 9,202 (4.2%)
OTHER 732 (0.3%)
NO INFORMATION 75 (0.0%)
OUTPATIENT TREATMENT FACILITY 35 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Drug Eluting Permanent Right Ventricular Or…, 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 (218,060 here).

Prosthesis 214,814 Set, Administration, Intravascular 207,687 Ventilator, Continuous, Facility Use 205,183 Automated External Defibrillators 263,821

Similar death-typed counts

Nearest other device types by death-typed report count (4,956 here), distinct from the volume row.

Defibrillator 4,732 Temporary Non-Roller Type Left Heart Suppor… 4,677 Ventilator, Non-Continuous 4,544 Pulse Generator, Permanent, Implantable 3,860

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.