2026 data FDA MAUDE openFDA

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

#22 of 1000 · 164,952 reports · 2000–2026

  • BOOK 164,952 reports
  • RANK #22 of 1000
  • DEATH 4,732 death-typed
  • INJ 82,793 injury-typed
  • MALF 77,252 malfunction
  • SPAN 2000–2026
  • PEAK 2017: 16,265
  • PHOTO Staple, Implantable

Nearest event-volume peer: Staple, Implantable (49 report gap)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) sits #22 of 1000 among tracked device types with 164,952 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 →

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 2.9% corpus 1.5% · above corpus mean (+1.3 pp)
  • INJ 50.2% corpus 30.4% · above corpus mean (+19.8 pp)
  • MALF 46.8% corpus 64.5% · below corpus mean (-17.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 26% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC.(CRM-SYLMAR) accounts for 25% of manufacturer-tagged reports · Top event location I is 41% 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 164,952 MAUDE reports, ranked #22 of 1000.

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

Event Types

Injury 82,793 (50.2%)
Malfunction 77,252 (46.8%)
Death 4,732 (2.9%)
136 (0.1%)
Other 39 (0.0%)

Patient Outcomes

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

70,000 (33.4%)
Required Intervention 41,563 (19.9%)
Hospitalization 34,026 (16.3%)
R 33,163 (15.8%)
Other 9,567 (4.6%)
L 6,786 (3.2%)
Death 4,676 (2.2%)
H 4,273 (2.0%)
Life Threatening 4,242 (2.0%)
O 944 (0.5%)
D 66 (0.0%)
S 29 (0.0%)
Congenital Anomaly 20 (0.0%)
Disability 20 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 31,037
Over-Sensing 27,782
Premature Discharge of Battery 8,632
Inappropriate/Inadequate Shock/Stimulation 5,929
High impedance 5,634
Pacing Problem 5,596
Failure to Capture 4,803
Inappropriate or Unexpected Reset 3,166
Failure to Interrogate 3,074
Device Sensing Problem 3,042
Device Dislodged or Dislocated 2,966
Signal Artifact/Noise 2,806
Battery Problem 2,513
Under-Sensing 1,963
Electrical /Electronic Property Problem 1,668
Capturing Problem 1,518
Mechanical Problem 1,428
High Capture Threshold 1,301
Incorrect Measurement 1,247
Appropriate Term/Code Not Available 1,104

Yearly Trend

00
2000: 1
02
2002: 41
03
2003: 202
04
2004: 617
05
2005: 558
06
2006: 354
07
2007: 921
08
2008: 3,021
09
2009: 4,177
10
2010: 5,668
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: 11,015
26
2026: 1,801

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

Event Locations

I 68,262 (41.4%)
67,800 (41.1%)
HOSPITAL 22,067 (13.4%)
OTHER 3,896 (2.4%)
OUTPATIENT TREATMENT FACILITY 1,644 (1.0%)
CLINIC - WALK IN, OTHER 620 (0.4%)
HOME 226 (0.1%)
NOT APPLICABLE 177 (0.1%)
NO INFORMATION 123 (0.1%)
UNKNOWN 106 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Defibrillator, 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 (164,952 here).

Similar death-typed counts

Nearest other device types by death-typed report count (4,732 here), distinct from the volume row.

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.