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2026 data FDA MAUDE openFDA FDA Class III

Implantable Cardioverter Defibrillator (Non-Crt)

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 Implantable Cardioverter Defibrillator HEAVY-BOOK · MAUDE

#10 of 1000 · 379,353 reports · 1992–2026

  • BOOK 379,353 reports
  • RANK #10 of 1000
  • DEATH 10,094 death-typed
  • INJ 226,424 injury-typed
  • MALF 141,519 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 28,702
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief (3,643 report gap)

Implantable Cardioverter Defibrillator (Non-Crt) sits #10 of 1000 among tracked device types with 379,353 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 →

Injury-coded reports run above the device-type norm

Implantable Cardioverter Defibrillator carries 59.7% INJURY-coded reports, 29.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.7% corpus 1.5% · above corpus mean (+1.2 pp)
  • INJ 59.7% corpus 30.3% · above corpus mean (+29.4 pp)
  • MALF 37.3% corpus 64.8% · below corpus mean (-27.5 pp)

Lead product-problem code Over-Sensing is 18% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 26% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Implantable Cardioverter Defibrillator in the event-volume neighbourhood

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

reports

What this shows Implantable Cardioverter Defibrillator (Non-Crt) carries 379,353 MAUDE reports, ranked #10 of 1000.

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

Event Types

Injury 226,424 (59.7%)
Malfunction 141,519 (37.3%)
Death 10,094 (2.7%)
671 (0.2%)
Other 644 (0.2%)
No answer provided 1 (0.0%)

Patient Outcomes

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

Hospitalization 111,515 (20.6%)
109,199 (20.2%)
R 106,146 (19.6%)
Required Intervention 86,722 (16.0%)
Other 43,233 (8.0%)
L 31,303 (5.8%)
H 25,455 (4.7%)
Life Threatening 13,732 (2.5%)
Death 9,883 (1.8%)
O 3,196 (0.6%)
S 216 (0.0%)
D 148 (0.0%)
Disability 64 (0.0%)
Congenital Anomaly 30 (0.0%)
Invalid Data 9 (0.0%)
C 1 (0.0%)

Top Product Problems

Over-Sensing 79,972
High impedance 59,335
Inappropriate/Inadequate Shock/Stimulation 48,505
Adverse Event Without Identified Device or Use Problem 44,468
Premature Discharge of Battery 30,831
Signal Artifact/Noise 30,012
Fracture 22,053
Impedance Problem 16,636
Device Sensing Problem 14,640
Pacing Problem 14,317
High Capture Threshold 13,603
Under-Sensing 11,681
Low impedance 10,731
Failure to Capture 9,932
Low Battery 9,599
Incorrect, Inadequate or Imprecise Result or Readings 8,750
Appropriate Device Problem Term/Code Not Available 7,982
Failure to Read Input Signal 7,914
Battery Problem 7,751
Normal 7,046

Yearly Trend

92
1992: 20
93
1993: 9
94
1994: 59
95
1995: 135
96
1996: 274
97
1997: 2,867
98
1998: 1,867
99
1999: 1,224
00
2000: 2,057
01
2001: 2,247
02
2002: 2,393
03
2003: 2,713
04
2004: 2,761
05
2005: 2,903
06
2006: 6,279
07
2007: 10,328
08
2008: 11,331
09
2009: 13,768
10
2010: 17,322
11
2011: 15,097
12
2012: 12,823
13
2013: 17,242
14
2014: 18,593
15
2015: 14,040
16
2016: 16,638
17
2017: 18,454
18
2018: 17,228
19
2019: 16,183
20
2020: 16,907
21
2021: 19,653
22
2022: 23,453
23
2023: 28,702
24
2024: 25,202
25
2025: 24,630
26
2026: 13,951

Reports in 2025 (24,630) held close to the prior two-year average of 26,952.

Related Entities for Implantable Cardioverter Defibrillator (Non-Crt)

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 70,441
MPRI 67,378
GUIDANT CRM CLONMEL IRELAND 29,669
MEDTRONIC PUERTO RICO, INC. 24,244
CARDIAC PACEMAKERS, INC 19,272
MEDTRONIC EUROPE SARL 12,118
ST. JUDE MEDICAL, INC., CRMD 12,020
CPI - DEL CARIBE 11,750
MEDTRONIC PUERTO RICO OPERATIONS CO. 10,356
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 9,917

Event Locations

165,570 (43.6%)
I 109,574 (28.9%)
HOSPITAL 83,759 (22.1%)
OTHER 10,489 (2.8%)
OUTPATIENT TREATMENT FACILITY 6,645 (1.8%)
HOME 1,070 (0.3%)
CLINIC - WALK IN, OTHER 567 (0.1%)
NO INFORMATION 440 (0.1%)
NOT APPLICABLE 422 (0.1%)
UNKNOWN 346 (0.1%)
INVALID DATA 266 (0.1%)
PATIENT'S HOME 98 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 54 (0.0%)
AMBULATORY SURGICAL FACILITY 20 (0.0%)
EMERGENCY ROOM 6 (0.0%)
NURSING HOME 6 (0.0%)
EXAMINATION ROOM 5 (0.0%)
OPERATING ROOM 3 (0.0%)
OUTDOORS 3 (0.0%)
PUBLIC VENUE 3 (0.0%)
HOSPICE 2 (0.0%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)
P 1 (0.0%)
PUBLIC BUILDING 1 (0.0%)
REHABILITATION CENTER 1 (0.0%)
STREET 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs MPRI →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Implantable Cardioverter Defibrillator: 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 (379,353 here).

Stimulator 375,710 System 431,358 Permanent Pacemaker Electrode 325,343 Sensor, Glucose, Invasive, Non-Adjunctive 324,715

Similar death-typed counts

Nearest other device types by death-typed report count (10,094 here), distinct from the volume row.

Coronary Drug-Eluting Stent 11,230 Aortic Valve 7,956 System 7,074 Temporary Non-Roller Type Left Heart Suppor… 5,667

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

Disclaimer: MAUDE figures for Implantable Cardioverter Defibrillator 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 Implantable Cardioverter Defibrillator; 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.