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2026 data FDA MAUDE openFDA FDA Class III

Device, Removal, Pacemaker Electrode, Percutaneous

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 Device LIGHT-BOOK · MAUDE

#557 of 1000 · 1,561 reports · 1993–2026

  • BOOK 1,561 reports
  • RANK #557 of 1000
  • DEATH 510 death-typed
  • INJ 926 injury-typed
  • MALF 115 malfunction
  • SPAN 1993–2026
  • PEAK 2013: 142
  • PHOTO Barrier

Nearest event-volume peer: Barrier, Absorbable, Adhesion (3 report gap)

Device, Removal, Pacemaker Electrode, Percutaneous sits #557 of 1000 among tracked device types with 1,561 MAUDE reports spanning 1993–2026. 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 → · Similar-volume device →

Malfunction reports sit below the device-type norm

Device carries 7.4% MALFUNCTION-coded reports, 57.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 32.7% corpus 1.5% · above corpus mean (+31.2 pp)
  • INJ 59.3% corpus 30.3% · above corpus mean (+29.0 pp)
  • MALF 7.4% corpus 64.8% · below corpus mean (-57.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 45% of coded problems · Top event location is 66% of location-tagged rows .

Device in the event-volume neighbourhood

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

reports

What this shows Device, Removal, Pacemaker Electrode, Percutaneous carries 1,561 MAUDE reports, ranked #557 of 1000.

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

Event Types

Injury 926 (59.3%)
Death 510 (32.7%)
Malfunction 115 (7.4%)
Other 7 (0.4%)
3 (0.2%)

Patient Outcomes

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

R 707 (23.9%)
L 599 (20.2%)
Hospitalization 534 (18.0%)
Death 460 (15.5%)
Life Threatening 248 (8.4%)
Required Intervention 158 (5.3%)
97 (3.3%)
Other 57 (1.9%)
D 48 (1.6%)
H 36 (1.2%)
S 10 (0.3%)
O 6 (0.2%)
Disability 3 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 683
Insufficient Device Problem Information 319
Device Operates Differently Than Expected 58
Break 57
Difficult to Remove 55
Failure to Advance 46
Material Separation 44
Unknown (for use when the device problem is not known) 39
Physical Resistance 38
Difficult to Advance 35
Fracture 30
Sticking 21
Device Inoperable 20
Entrapment of Device 20
Appropriate Device Problem Term/Code Not Available 15
Positioning Problem 14
Kinked 11
Improper or Incorrect Procedure or Method 10
Difficult to Insert 9
Deformation Due to Compressive Stress 8

Yearly Trend

93
1993: 1
97
1997: 6
98
1998: 2
99
1999: 4
00
2000: 1
03
2003: 3
04
2004: 4
05
2005: 3
06
2006: 2
07
2007: 7
08
2008: 25
09
2009: 46
10
2010: 79
11
2011: 80
12
2012: 134
13
2013: 142
14
2014: 121
15
2015: 73
16
2016: 91
17
2017: 96
18
2018: 77
19
2019: 66
20
2020: 77
21
2021: 83
22
2022: 60
23
2023: 55
24
2024: 70
25
2025: 68
26
2026: 85

Reports in 2025 (68) held close to the prior two-year average of 63.

Related Entities for Device, Removal, Pacemaker Electrode, Percutaneous

Event Locations

1,024 (65.6%)
I 501 (32.1%)
HOSPITAL 33 (2.1%)
NO INFORMATION 3 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Device: 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 (1,561 here).

Barrier, Absorbable, Adhesion 1,558 Prosthesis 1,564 Mattress, Flotation Therapy, Non-Powered 1,569 Modular Electromechanical Surgical System 1,552

Similar death-typed counts

Nearest other device types by death-typed report count (510 here), distinct from the volume row.

Detector And Alarm, Arrhythmia 505 Generator, Oxygen, Portable 519 Drug-Eluting Peripheral Transluminal Angiop… 528 Intracranial Neurovascular Stent 537

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

Disclaimer: MAUDE figures for Device 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 Device; 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.