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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.3680 (Cardiovascular panel).

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FDA MAUDE casebook

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

#502 of 1000 · 2,012 reports · 1992–2026

  • BOOK 2,012 reports
  • RANK #502 of 1000
  • DEATH 65 death-typed
  • INJ 439 injury-typed
  • MALF 1,488 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 212
  • PHOTO Valve, Pulmonary

Nearest event-volume peer: Valve, Pulmonary (4 report gap)

Electrode, Pacemaker, Temporary sits #502 of 1000 among tracked device types with 2,012 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 →

Malfunction reports run above the device-type norm

Electrode, Pacemaker, Temporary carries 74.0% MALFUNCTION-coded reports, 9.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.2% corpus 1.5% · above corpus mean (+1.7 pp)
  • INJ 21.8% corpus 30.3% · below corpus mean (-8.5 pp)
  • MALF 74.0% corpus 64.8% · above corpus mean (+9.1 pp)

Lead product-problem code Pacing Problem is 38% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES, PR accounts for 34% of manufacturer-tagged reports · Top event location is 51% 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 2,012 MAUDE reports, ranked #502 of 1000.

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

Event Types

Malfunction 1,488 (74.0%)
Injury 439 (21.8%)
Death 65 (3.2%)
10 (0.5%)
Other 10 (0.5%)

Patient Outcomes

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

1,247 (57.3%)
Other 336 (15.4%)
Required Intervention 219 (10.1%)
R 112 (5.1%)
Life Threatening 85 (3.9%)
Death 53 (2.4%)
Hospitalization 48 (2.2%)
L 43 (2.0%)
H 10 (0.5%)
O 10 (0.5%)
D 5 (0.2%)
Disability 5 (0.2%)
S 2 (0.1%)

Top Product Problems

Pacing Problem 644
Break 194
Inflation Problem 115
Adverse Event Without Identified Device or Use Problem 114
No Pacing 95
Material Separation 73
Fracture 59
Material Integrity Problem 40
Failure to Capture 37
Appropriate Device Problem Term/Code Not Available 35
Insufficient Device Problem Information 34
Replace 34
Detachment of Device or Device Component 29
Material Rupture 29
Detachment Of Device Component 27
Fluid/Blood Leak 27
Failure to Sense 26
Disconnection 22
Explanted 22
Unknown (for use when the device problem is not known) 22

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: 97

Reports in 2025 (139) held close to the prior two-year average of 201.

Related Entities for Electrode, Pacemaker, Temporary

Top Manufacturers

EDWARDS LIFESCIENCES, PR 437
C.R. BARD, INC. (COVINGTON) -1018233 217
ETHICON INC. 159
EDWARDS LIFESCIENCES 130
ST. JUDE MEDICAL 120
C.R. BARD INC. (COVINGTON) -1018233 72
MEDTRONIC, INC. 62
EDWARDS LIFESCIENCES PR 51
MEDTRONIC HEART VALVES DIVISION 50

Event Locations

1,025 (50.9%)
I 581 (28.9%)
HOSPITAL 378 (18.8%)
NO INFORMATION 14 (0.7%)
INVALID DATA 4 (0.2%)
OTHER 4 (0.2%)
NOT APPLICABLE 2 (0.1%)
HOME 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)
PATIENT'S HOME 1 (0.0%)
UNKNOWN 1 (0.0%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Electrode, Pacemaker, Temporary: 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 (2,012 here).

Valve, Pulmonary 2,016 Pouch, Colostomy 2,020 Apparatus 2,026 Tricuspid Valve Repair Device 2,028

Similar death-typed counts

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

Pancreatic Stent 65 Syringe, Piston 66 Colonoscope And Accessories, Flexible/Rigid 63 Dressing, Wound, Drug 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.