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2026 data FDA MAUDE openFDA

Electrode, Pacemaker, Temporary

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.

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FDA MAUDE casebook

openFDA event book Electrode, Pacemaker, Temporary LIGHT-BOOK · MAUDE

#496 of 1000 · 1,935 reports · 1992–2026

  • BOOK 1,935 reports
  • RANK #496 of 1000
  • DEATH 65 death-typed
  • INJ 427 injury-typed
  • MALF 1,423 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 212
  • PHOTO Valve, Pulmonary

Nearest event-volume peer: Valve, Pulmonary (0 report gap)

Electrode, Pacemaker, Temporary sits #496 of 1000 among tracked device types with 1,935 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 →

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 3.4% corpus 1.5% · above corpus mean (+1.8 pp)
  • INJ 22.1% corpus 30.4% · below corpus mean (-8.4 pp)
  • MALF 73.5% corpus 64.5% · above corpus mean (+9.0 pp)

Lead product-problem code Pacing Problem is 33% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES, PR accounts for 35% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Electrode, Pacemaker, Temporary in the event-volume neighbourhood

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

reports

What this shows Electrode, Pacemaker, Temporary carries 1,935 MAUDE reports, ranked #496 of 1000.

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

Event Types

Malfunction 1,423 (73.5%)
Injury 427 (22.1%)
Death 65 (3.4%)
10 (0.5%)
Other 10 (0.5%)

Patient Outcomes

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

1,212 (57.5%)
Other 315 (14.9%)
Required Intervention 214 (10.1%)
R 109 (5.2%)
Life Threatening 84 (4.0%)
Death 54 (2.6%)
Hospitalization 48 (2.3%)
L 43 (2.0%)
H 9 (0.4%)
O 9 (0.4%)
D 5 (0.2%)
Disability 5 (0.2%)
S 2 (0.1%)

Top Product Problems

Pacing Problem 386
Break 138
Inflation Problem 101
Adverse Event Without Identified Device or Use Problem 95
No Pacing 84
Material Separation 66
Material Integrity Problem 39
Fracture 30
Detachment of Device or Device Component 27
Insufficient Information 23
Material Rupture 22
Patient Device Interaction Problem 20
Deformation Due to Compressive Stress 19
Failure to Capture 17
Burst Container or Vessel 16
Connection Problem 16
Failure to Sense 16
Appropriate Term/Code Not Available 15
Material Too Rigid or Stiff 14
Accessory Incompatible 12

Yearly Trend

92
1992: 3
94
1994: 2
95
1995: 2
96
1996: 10
97
1997: 11
98
1998: 17
99
1999: 20
00
2000: 12
01
2001: 29
02
2002: 22
03
2003: 23
04
2004: 15
05
2005: 13
06
2006: 19
07
2007: 25
08
2008: 18
09
2009: 44
10
2010: 48
11
2011: 35
12
2012: 68
13
2013: 74
14
2014: 68
15
2015: 81
16
2016: 90
17
2017: 79
18
2018: 91
19
2019: 130
20
2020: 83
21
2021: 125
22
2022: 117
23
2023: 212
24
2024: 190
25
2025: 139
26
2026: 20

Related Entities for Electrode, Pacemaker, Temporary

Top Manufacturers

EDWARDS LIFESCIENCES, PR 436
C.R. BARD, INC. (COVINGTON) -1018233 219
ETHICON INC. 148
EDWARDS LIFESCIENCES 127
ST. JUDE MEDICAL 120
MEDTRONIC, INC. 62
MEDTRONIC HEART VALVES DIVISION 50
EDWARDS LIFESCIENCES PR 47
C.R. BARD INC. (COVINGTON) -1018233 46

Event Locations

948 (49.0%)
I 582 (30.1%)
HOSPITAL 377 (19.5%)
NO INFORMATION 14 (0.7%)
INVALID DATA 4 (0.2%)
OTHER 4 (0.2%)
NOT APPLICABLE 2 (0.1%)
HOME 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
PATIENT'S HOME 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare EDWARDS LIFESCIENCES, PR vs C.R. BARD, INC. (COVINGTON) -1018233 →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Electrode, Pacemaker, Temporary, 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 (1,935 here).

Valve, Pulmonary 1,935 Hydrogel Spacer 1,926 Trocar 1,947 Temporary Non-Roller Type Right Heart Suppo… 1,948

Similar death-typed counts

Nearest other device types by death-typed report count (65 here), distinct from the volume row.

Needle, Hypodermic, Single Lumen 65 Pancreatic Stent 64 Syringe, Piston 66 Colonoscope And Accessories, Flexible/Rigid 63

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

Disclaimer: MAUDE figures for Electrode, Pacemaker, Temporary 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 Electrode, Pacemaker, Temporary; 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.