2026 data FDA MAUDE openFDA FDA Class III

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

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 MAUDE casebook

openFDA event book Defibrillator HEAVY-BOOK · MAUDE

#23 of 1000 · 169,573 reports · 2000–2026

  • BOOK 169,573 reports
  • RANK #23 of 1000
  • DEATH 4,802 death-typed
  • INJ 84,628 injury-typed
  • MALF 79,968 malfunction
  • SPAN 2000–2026
  • PEAK 2017: 16,265
  • PHOTO Staple, Implantable

Nearest event-volume peer: Staple, Implantable (39 report gap)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) sits #23 of 1000 among tracked device types with 169,573 MAUDE reports spanning 2000–2026. 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

Defibrillator carries 49.9% INJURY-coded reports, 19.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.8% corpus 1.5% · above corpus mean (+1.3 pp)
  • INJ 49.9% corpus 30.3% · above corpus mean (+19.6 pp)
  • MALF 47.2% corpus 64.8% · below corpus mean (-17.7 pp)

Lead product-problem code Over-Sensing is 22% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC.(CRM-SYLMAR) accounts for 25% of manufacturer-tagged reports · Top event location is 43% of location-tagged rows .

Defibrillator in the event-volume neighbourhood

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

reports

What this shows Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) carries 169,573 MAUDE reports, ranked #23 of 1000.

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

Event Types

Injury 84,628 (49.9%)
Malfunction 79,968 (47.2%)
Death 4,802 (2.8%)
136 (0.1%)
Other 39 (0.0%)

Patient Outcomes

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

72,190 (33.8%)
Required Intervention 42,307 (19.8%)
Hospitalization 34,351 (16.1%)
R 33,488 (15.7%)
Other 9,787 (4.6%)
L 6,832 (3.2%)
Death 4,739 (2.2%)
H 4,583 (2.1%)
Life Threatening 4,358 (2.0%)
O 973 (0.5%)
D 69 (0.0%)
S 30 (0.0%)
Congenital Anomaly 20 (0.0%)
Disability 20 (0.0%)

Top Product Problems

Over-Sensing 37,674
Adverse Event Without Identified Device or Use Problem 35,904
Premature Discharge of Battery 18,649
High impedance 9,433
Inappropriate/Inadequate Shock/Stimulation 8,783
Pacing Problem 8,213
Failure to Capture 6,880
Device Sensing Problem 4,406
Device Dislodged or Dislocated 4,099
Inappropriate or Unexpected Reset 4,094
Low Battery 4,075
Failure to Interrogate 3,948
Signal Artifact/Noise 3,219
Appropriate Device Problem Term/Code Not Available 3,153
Battery Problem 3,117
Under-Sensing 2,777
Device Operates Differently Than Expected 2,546
Mechanical Problem 2,430
Premature Elective Replacement Indicator 2,426
Electrical /Electronic Property Problem 2,298

Yearly Trend

00
2000: 1
02
2002: 41
03
2003: 202
04
2004: 617
05
2005: 560
06
2006: 353
07
2007: 925
08
2008: 3,021
09
2009: 4,177
10
2010: 5,669
11
2011: 5,944
12
2012: 5,582
13
2013: 7,373
14
2014: 10,731
15
2015: 7,828
16
2016: 13,255
17
2017: 16,265
18
2018: 8,348
19
2019: 7,266
20
2020: 9,609
21
2021: 10,134
22
2022: 10,646
23
2023: 11,897
24
2024: 11,698
25
2025: 11,014
26
2026: 6,417

Reports in 2025 (11,014) held close to the prior two-year average of 11,798.

Related Entities for Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Event Locations

72,430 (42.7%)
I 68,245 (40.2%)
HOSPITAL 22,071 (13.0%)
OTHER 3,896 (2.3%)
OUTPATIENT TREATMENT FACILITY 1,648 (1.0%)
CLINIC - WALK IN, OTHER 620 (0.4%)
HOME 227 (0.1%)
NOT APPLICABLE 177 (0.1%)
NO INFORMATION 123 (0.1%)
UNKNOWN 105 (0.1%)
INVALID DATA 8 (0.0%)
PATIENT'S HOME 8 (0.0%)
EXAMINATION ROOM 7 (0.0%)
HOSPICE 2 (0.0%)
OUTDOORS 2 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
NURSING HOME 1 (0.0%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)

Compare ST. JUDE MEDICAL, INC.(CRM-SYLMAR) vs ST. JUDE MEDICAL, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for 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.

Disclaimer: MAUDE figures for 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 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.