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2026 data FDA MAUDE openFDA

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

#31 of 1000 · 132,799 reports · 1997–2026

  • BOOK 132,799 reports
  • RANK #31 of 1000
  • DEATH 3,030 death-typed
  • INJ 74,889 injury-typed
  • MALF 54,780 malfunction
  • SPAN 1997–2026
  • PEAK 2025: 11,639
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) (4,823 report gap)

Permanent Defibrillator Electrodes sits #31 of 1000 among tracked device types with 132,799 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 56.4% corpus 30.4% · above corpus mean (+26.0 pp)
  • MALF 41.3% corpus 64.5% · below corpus mean (-23.3 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 48% 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 132,799 MAUDE reports, ranked #31 of 1000.

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

Event Types

Injury 74,889 (56.4%)
Malfunction 54,780 (41.3%)
Death 3,030 (2.3%)
79 (0.1%)
Other 21 (0.0%)

Patient Outcomes

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

46,494 (27.3%)
Required Intervention 43,171 (25.4%)
Hospitalization 35,792 (21.1%)
R 22,416 (13.2%)
L 10,455 (6.1%)
H 3,823 (2.2%)
Death 2,980 (1.8%)
Other 2,149 (1.3%)
Life Threatening 2,033 (1.2%)
O 607 (0.4%)
D 41 (0.0%)
Congenital Anomaly 35 (0.0%)
S 22 (0.0%)
Disability 10 (0.0%)
C 2 (0.0%)

Top Product Problems

Over-Sensing 21,526
High impedance 18,447
Adverse Event Without Identified Device or Use Problem 15,527
Device Dislodged or Dislocated 9,314
Signal Artifact/Noise 8,328
Inappropriate/Inadequate Shock/Stimulation 7,215
Failure to Capture 7,091
High Capture Threshold 6,836
Break 5,654
Fracture 4,937
Low impedance 4,820
Capturing Problem 4,572
Ambient Noise Problem 4,334
Device Sensing Problem 3,920
Impedance Problem 3,195
Under-Sensing 2,461
Pacing Problem 1,659
Decreased Sensitivity 1,564
Defective Device 1,092
Insufficient Information 1,027

Yearly Trend

97
1997: 3
03
2003: 5
04
2004: 6
05
2005: 6
06
2006: 23
07
2007: 48
08
2008: 63
09
2009: 103
10
2010: 1,796
11
2011: 6,003
12
2012: 8,519
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: 8,324
20
2020: 8,020
21
2021: 8,058
22
2022: 7,636
23
2023: 10,441
24
2024: 9,362
25
2025: 11,639
26
2026: 1,810

Related Entities for Permanent Defibrillator Electrodes

Top Manufacturers

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 23,648
BIOTRONIK SE & CO. KG 18,128
CPI - DEL CARIBE 14,568
BOSTON SCIENTIFIC CORPORATION 13,577
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 12,410
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 12,133
MPRI 10,413
ST. JUDE MEDICAL, INC., CRMD 8,654
ABBOTT 6,352
ST. JUDE MEDICAL, INC. 2,713

Event Locations

63,833 (48.1%)
I 51,980 (39.1%)
HOSPITAL 14,862 (11.2%)
OTHER 1,794 (1.4%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Permanent Defibrillator Electrodes, 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 (132,799 here).

Prosthesis, Hip, Semi-Constrained 137,622 Coronary Drug-Eluting Stent 127,490 Wearable Automated External Defibrillator 143,491 Device, Hemostasis, Vascular 121,291

Similar death-typed counts

Nearest other device types by death-typed report count (3,030 here), distinct from the volume row.

Stimulator 2,889 System, Peritoneal, Automatic Delivery 3,401 Dialyzer 2,561 Set 2,395

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.