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2026 data FDA MAUDE openFDA FDA Class III

Permanent Defibrillator 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 Permanent Defibrillator Electrodes HEAVY-BOOK · MAUDE

#32 of 1000 · 137,720 reports · 1997–2026

  • BOOK 137,720 reports
  • RANK #32 of 1000
  • DEATH 3,081 death-typed
  • INJ 77,809 injury-typed
  • MALF 56,728 malfunction
  • SPAN 1997–2026
  • PEAK 2025: 11,641
  • PHOTO System

Nearest event-volume peer: System, Surgical, Computer Controlled Instrument (260 report gap)

Permanent Defibrillator Electrodes sits #32 of 1000 among tracked device types with 137,720 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

Permanent Defibrillator Electrodes carries 56.5% INJURY-coded reports, 26.2pp 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 56.5% corpus 30.3% · above corpus mean (+26.2 pp)
  • MALF 41.2% corpus 64.8% · below corpus mean (-23.6 pp)

Lead product-problem code Over-Sensing is 16% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC.(CRM-SYLMAR) accounts for 19% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .

Permanent Defibrillator Electrodes in the event-volume neighbourhood

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

reports

What this shows Permanent Defibrillator Electrodes carries 137,720 MAUDE reports, ranked #32 of 1000.

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

Event Types

Injury 77,809 (56.5%)
Malfunction 56,728 (41.2%)
Death 3,081 (2.2%)
79 (0.1%)
Other 23 (0.0%)

Patient Outcomes

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

48,092 (27.4%)
Required Intervention 44,575 (25.4%)
Hospitalization 36,391 (20.8%)
R 23,045 (13.2%)
L 10,511 (6.0%)
H 4,518 (2.6%)
Death 3,024 (1.7%)
Other 2,226 (1.3%)
Life Threatening 2,097 (1.2%)
O 628 (0.4%)
D 47 (0.0%)
Congenital Anomaly 36 (0.0%)
S 22 (0.0%)
Disability 10 (0.0%)
C 2 (0.0%)

Top Product Problems

Over-Sensing 31,418
High impedance 27,593
Adverse Event Without Identified Device or Use Problem 19,247
Device Dislodged or Dislocated 15,051
Break 12,163
Inappropriate/Inadequate Shock/Stimulation 11,653
Failure to Capture 11,150
High Capture Threshold 11,134
Signal Artifact/Noise 9,103
Low impedance 8,276
Fracture 7,423
Device Sensing Problem 6,873
Capturing Problem 5,150
Ambient Noise Problem 5,081
Impedance Problem 4,233
Under-Sensing 3,438
Appropriate Device Problem Term/Code Not Available 2,936
Insufficient Device Problem Information 2,878
Pacing Problem 2,820
Decreased Sensitivity 2,695

Yearly Trend

97
1997: 3
03
2003: 5
04
2004: 6
05
2005: 6
06
2006: 23
07
2007: 49
08
2008: 63
09
2009: 103
10
2010: 1,797
11
2011: 6,004
12
2012: 8,524
13
2013: 7,224
14
2014: 9,530
15
2015: 8,839
16
2016: 8,567
17
2017: 8,452
18
2018: 8,322
19
2019: 8,325
20
2020: 8,022
21
2021: 8,060
22
2022: 7,637
23
2023: 10,441
24
2024: 9,363
25
2025: 11,641
26
2026: 6,714

Reports in 2025 (11,641) held close to the prior two-year average of 9,902.

Related Entities for Permanent Defibrillator Electrodes

Top Manufacturers

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 23,806
BIOTRONIK SE & CO. KG 18,786
BOSTON SCIENTIFIC CORPORATION 15,143
CPI - DEL CARIBE 14,565
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 12,410
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 12,133
MPRI 10,401
ST. JUDE MEDICAL, INC., CRMD 8,654
ABBOTT 6,489
ST. JUDE MEDICAL, INC. 2,714

Event Locations

68,776 (49.9%)
I 51,947 (37.7%)
HOSPITAL 14,872 (10.8%)
OTHER 1,795 (1.3%)
OUTPATIENT TREATMENT FACILITY 114 (0.1%)
CLINIC - WALK IN, OTHER 85 (0.1%)
HOME 63 (0.0%)
NO INFORMATION 58 (0.0%)
EXAMINATION ROOM 2 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
33 1 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
EMERGENCY ROOM 1 (0.0%)
INVALID DATA 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare ST. JUDE MEDICAL, INC.(CRM-SYLMAR) vs BIOTRONIK SE & CO. KG →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Permanent Defibrillator Electrodes: 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 (137,720 here).

System 137,980 Prosthesis, Hip, Semi-Constrained 138,399 Coronary Drug-Eluting Stent 128,715 Wearable Automated External Defibrillator 148,775

Similar death-typed counts

Nearest other device types by death-typed report count (3,081 here), distinct from the volume row.

Stimulator 2,917 System, Peritoneal, Automatic Delivery 3,434 Dialyzer 2,583 Set 2,402

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

Disclaimer: MAUDE figures for Permanent Defibrillator Electrodes 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 Permanent Defibrillator Electrodes; 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.