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2026 data FDA MAUDE openFDA

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 · 369,312 reports · 1992–2026

  • BOOK 369,312 reports
  • RANK #10 of 1000
  • DEATH 10,004 death-typed
  • INJ 220,498 injury-typed
  • MALF 137,495 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 28,702
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief (7,278 report gap)

Implantable Cardioverter Defibrillator (Non-Crt) sits #10 of 1000 among tracked device types with 369,312 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 →

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 2.7% corpus 1.5% · above corpus mean (+1.2 pp)
  • INJ 59.7% corpus 30.4% · above corpus mean (+29.3 pp)
  • MALF 37.2% corpus 64.5% · below corpus mean (-27.3 pp)

Lead product-problem code Over-Sensing is 17% of coded problems · Lead manufacturer MPRI accounts for 26% of manufacturer-tagged reports · Top event location is 42% 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 369,312 MAUDE reports, ranked #10 of 1000.

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

Event Types

Injury 220,498 (59.7%)
Malfunction 137,495 (37.2%)
Death 10,004 (2.7%)
671 (0.2%)
Other 643 (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 110,105 (20.8%)
106,076 (20.0%)
R 104,768 (19.7%)
Required Intervention 84,982 (16.0%)
Other 42,696 (8.0%)
L 31,114 (5.9%)
H 24,089 (4.5%)
Life Threatening 13,301 (2.5%)
Death 9,803 (1.8%)
O 3,119 (0.6%)
S 214 (0.0%)
D 145 (0.0%)
Disability 63 (0.0%)
Congenital Anomaly 31 (0.0%)
Invalid Data 9 (0.0%)
C 1 (0.0%)

Top Product Problems

Over-Sensing 51,281
Adverse Event Without Identified Device or Use Problem 35,925
High impedance 34,477
Inappropriate/Inadequate Shock/Stimulation 29,138
Signal Artifact/Noise 23,632
Premature Discharge of Battery 23,269
Fracture 14,692
Impedance Problem 11,752
High Capture Threshold 10,661
Device Sensing Problem 10,121
Pacing Problem 8,497
Incorrect, Inadequate or Imprecise Result or Readings 8,388
Under-Sensing 7,921
Failure to Read Input Signal 6,975
Battery Problem 6,851
Low impedance 6,129
Failure to Capture 4,619
Device Dislodged or Dislocated 4,466
Capturing Problem 3,797
Decreased Sensitivity 3,394

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: 2,904
06
2006: 6,279
07
2007: 10,335
08
2008: 11,327
09
2009: 13,768
10
2010: 17,321
11
2011: 15,096
12
2012: 12,820
13
2013: 17,242
14
2014: 18,594
15
2015: 14,040
16
2016: 16,638
17
2017: 18,454
18
2018: 17,228
19
2019: 16,184
20
2020: 16,909
21
2021: 19,655
22
2022: 23,454
23
2023: 28,702
24
2024: 25,203
25
2025: 24,632
26
2026: 3,901

Related Entities for Implantable Cardioverter Defibrillator (Non-Crt)

Top Manufacturers

MPRI 67,389
BOSTON SCIENTIFIC CORPORATION 66,135
GUIDANT CRM CLONMEL IRELAND 29,664
MEDTRONIC PUERTO RICO, INC. 24,245
CARDIAC PACEMAKERS, INC 19,280
ST. JUDE MEDICAL, INC., CRMD 12,020
CPI - DEL CARIBE 11,751
MEDTRONIC EUROPE SARL 11,112
MEDTRONIC PUERTO RICO OPERATIONS CO. 10,077
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 9,867

Event Locations

155,416 (42.1%)
I 109,692 (29.7%)
HOSPITAL 83,751 (22.7%)
OTHER 10,489 (2.8%)
OUTPATIENT TREATMENT FACILITY 6,648 (1.8%)
HOME 1,070 (0.3%)
CLINIC - WALK IN, OTHER 567 (0.2%)
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 MPRI vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Implantable Cardioverter 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 (369,312 here).

Stimulator 362,034 Sensor, Glucose, Invasive, Non-Adjunctive 316,062 Permanent Pacemaker Electrode 313,884 System 429,427

Similar death-typed counts

Nearest other device types by death-typed report count (10,004 here), distinct from the volume row.

Coronary Drug-Eluting Stent 11,160 Aortic Valve 7,440 System 7,020 Drug Eluting Permanent Right Ventricular Or… 4,956

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.