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2026 data FDA MAUDE openFDA FDA Class II

Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

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 Class II (moderate risk, special controls required), regulated under 21 CFR §870.2800 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Recorder, Event, Implantable Cardiac, MID-BOOK · MAUDE

#204 of 1000 · 11,214 reports · 2001–2026

  • BOOK 11,214 reports
  • RANK #204 of 1000
  • DEATH 19 death-typed
  • INJ 1,581 injury-typed
  • MALF 9,611 malfunction
  • SPAN 2001–2026
  • PEAK 2018: 1,819
  • PHOTO Compressor

Nearest event-volume peer: Compressor, Cardiac, External (6 report gap)

Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) sits #204 of 1000 among tracked device types with 11,214 MAUDE reports spanning 2001–2026. 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 →

Malfunction reports run above the device-type norm

Recorder, Event, Implantable Cardiac, carries 85.7% MALFUNCTION-coded reports, 20.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 14.1% corpus 30.3% · below corpus mean (-16.2 pp)
  • MALF 85.7% corpus 64.8% · above corpus mean (+20.9 pp)

Lead product-problem code Under-Sensing is 37% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC.(CRM-SYLMAR) accounts for 59% of manufacturer-tagged reports · Top event location I is 51% of location-tagged rows .

Recorder, Event, Implantable Cardiac, in the event-volume neighbourhood

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

reports

What this shows Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) carries 11,214 MAUDE reports, ranked #204 of 1000.

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

Event Types

Malfunction 9,611 (85.7%)
Injury 1,581 (14.1%)
Death 19 (0.2%)
2 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

9,541 (83.9%)
Required Intervention 1,358 (11.9%)
R 183 (1.6%)
Hospitalization 179 (1.6%)
Other 74 (0.7%)
Death 19 (0.2%)
O 11 (0.1%)
Life Threatening 5 (0.0%)
H 1 (0.0%)
L 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Under-Sensing 4,557
Failure to Interrogate 1,627
Over-Sensing 1,327
Premature Discharge of Battery 619
Adverse Event Without Identified Device or Use Problem 557
Data Problem 479
Incorrect Measurement 408
Signal Artifact/Noise 402
Pacemaker Found in Back-Up Mode 300
Failure to Sense 266
Device Displays Incorrect Message 247
Inappropriate or Unexpected Reset 241
Device Sensing Problem 182
Incorrect, Inadequate or Imprecise Result or Readings 175
Interrogation Problem 175
Device Operates Differently Than Expected 161
Sensing Intermittently 144
Wireless Communication Problem 144
Migration or Expulsion of Device 126
Incorrect Interpretation of Signal 120

Yearly Trend

01
2001: 1
02
2002: 5
04
2004: 1
08
2008: 3
09
2009: 12
10
2010: 14
11
2011: 21
12
2012: 30
13
2013: 144
14
2014: 598
15
2015: 235
16
2016: 194
17
2017: 226
18
2018: 1,819
19
2019: 1,593
20
2020: 1,100
21
2021: 832
22
2022: 628
23
2023: 828
24
2024: 975
25
2025: 1,123
26
2026: 832

Reports in 2025 (1,123) held close to the prior two-year average of 902.

Related Entities for Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

Top Manufacturers

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 6,360
ABBOTT 1,560
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1,037
ST. JUDE MEDICAL, INC. 671
ABBOTT MEDICAL (CRM-SYLMAR) 461
ST. JUDE MEDICAL, INC., CRMD 422
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 197
ST. JUDE MEDICAL, INC. (CRM-KISTA) 83

Event Locations

I 5,714 (51.0%)
4,886 (43.6%)
HOSPITAL 355 (3.2%)
OTHER 241 (2.1%)
NO INFORMATION 9 (0.1%)
CLINIC - WALK IN, OTHER 6 (0.1%)
EXAMINATION ROOM 1 (0.0%)
HOME 1 (0.0%)
UNKNOWN 1 (0.0%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Recorder, Event, Implantable Cardiac,: 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 (11,214 here).

Compressor, Cardiac, External 11,220 Ventilator, Continuous, Non-Life-Supporting 11,195 Dermal Cooling Pack/Vacuum/Massager 11,387 Catheter 11,392

Similar death-typed counts

Nearest other device types by death-typed report count (19 here), distinct from the volume row.

Electrode, Electrosurgical 19 Pacemaker, Cardiac, External Transcutaneous 19 Sleeve, Limb, Compressible 19 Accelerator, Linear, Medical 20

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

Disclaimer: MAUDE figures for Recorder, Event, Implantable Cardiac, 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 Recorder, Event, Implantable Cardiac,; 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.