2026 data FDA MAUDE openFDA

Pacemaker/Icd/Crt Non-Implanted Components

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 Pacemaker/Icd/Crt Non-Implanted Components MID-BOOK · MAUDE

#167 of 1000 · 15,411 reports · 2013–2026

  • BOOK 15,411 reports
  • RANK #167 of 1000
  • DEATH 2 death-typed
  • INJ 75 injury-typed
  • MALF 15,333 malfunction
  • SPAN 2013–2026
  • PEAK 2025: 8,596
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (199 report gap)

Pacemaker/Icd/Crt Non-Implanted Components sits #167 of 1000 among tracked device types with 15,411 MAUDE reports spanning 2013–2026. 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.5% corpus 30.4% · below corpus mean (-30.0 pp)
  • MALF 99.5% corpus 64.5% · above corpus mean (+35.0 pp)

Lead product-problem code Computer Software Problem is 48% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 87% of manufacturer-tagged reports · Top event location is 98% of location-tagged rows .

Pacemaker/Icd/Crt Non-Implanted Components in the event-volume neighbourhood

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

reports

What this shows Pacemaker/Icd/Crt Non-Implanted Components carries 15,411 MAUDE reports, ranked #167 of 1000.

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

Event Types

Malfunction 15,333 (99.5%)
Injury 75 (0.5%)
Death 2 (0.0%)
1 (0.0%)

Patient Outcomes

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

15,084 (99.2%)
Life Threatening 27 (0.2%)
Required Intervention 25 (0.2%)
Other 24 (0.2%)
R 16 (0.1%)
Hospitalization 14 (0.1%)
L 10 (0.1%)
H 5 (0.0%)
Death 2 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Computer Software Problem 11,342
Computer Operating System Problem 8,599
Key or Button Unresponsive/not Working 1,031
Communication or Transmission Problem 972
Defective Device 742
Display or Visual Feedback Problem 162
Application Program Problem 155
Output Problem 149
Data Problem 141
Wireless Communication Problem 98
Inadequate User Interface 67
Device Operates Differently Than Expected 65
Failure to Power Up 59
Power Problem 58
Application Program Freezes, Becomes Nonfunctional 44
Defective Component 35
Overheating of Device 35
Connection Problem 34
Interrogation Problem 31
Pacing Problem 31

Yearly Trend

13
2013: 1
14
2014: 8
15
2015: 46
16
2016: 29
17
2017: 40
18
2018: 57
19
2019: 40
20
2020: 40
21
2021: 102
22
2022: 267
23
2023: 1,086
24
2024: 447
25
2025: 8,596
26
2026: 4,652

Related Entities for Pacemaker/Icd/Crt Non-Implanted Components

Event Locations

15,128 (98.2%)
I 217 (1.4%)
HOME 32 (0.2%)
HOSPITAL 14 (0.1%)
NO INFORMATION 13 (0.1%)
OTHER 5 (0.0%)
NURSING HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare MEDTRONIC, INC. vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Pacemaker/Icd/Crt Non-Implanted Components, 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 (15,411 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Pacemaker/Icd/Crt Non-Implanted Components 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 Pacemaker/Icd/Crt Non-Implanted Components; 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.