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2026 data FDA MAUDE openFDA FDA Class II

Recorder, Event, Implantable Cardiac, (With 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 §870.1025 (Cardiovascular panel).

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FDA MAUDE casebook

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

#191 of 1000 · 12,726 reports · 2001–2026

  • BOOK 12,726 reports
  • RANK #191 of 1000
  • DEATH 4 death-typed
  • INJ 2,193 injury-typed
  • MALF 10,529 malfunction
  • SPAN 2001–2026
  • PEAK 2025: 3,415
  • PHOTO Analyzer

Nearest event-volume peer: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (9 report gap)

Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) sits #191 of 1000 among tracked device types with 12,726 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 82.7% MALFUNCTION-coded reports, 17.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 17.2% corpus 30.3% · below corpus mean (-13.1 pp)
  • MALF 82.7% corpus 64.8% · above corpus mean (+17.9 pp)

Lead product-problem code Reset Problem is 16% of coded problems · Lead manufacturer MEDTRONIC SINGAPORE OPERATIONS accounts for 78% of manufacturer-tagged reports · Top event location is 93% 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, (With Arrhythmia Detection) carries 12,726 MAUDE reports, ranked #191 of 1000.

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

Event Types

Malfunction 10,529 (82.7%)
Injury 2,193 (17.2%)
Death 4 (0.0%)

Patient Outcomes

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

9,996 (74.0%)
Hospitalization 1,670 (12.4%)
Required Intervention 803 (5.9%)
R 443 (3.3%)
H 407 (3.0%)
Other 148 (1.1%)
O 23 (0.2%)
Death 4 (0.0%)
L 3 (0.0%)
Disability 3 (0.0%)
Life Threatening 3 (0.0%)

Top Product Problems

Reset Problem 2,424
Premature Discharge of Battery 1,864
Adverse Event Without Identified Device or Use Problem 1,289
Output Problem 1,260
Inappropriate or Unexpected Reset 1,238
Signal Artifact/Noise 1,090
Under-Sensing 983
Over-Sensing 765
Device Sensing Problem 680
Data Problem 679
Migration or Expulsion of Device 643
Communication or Transmission Problem 399
Battery Problem 342
Electromagnetic Interference 243
Failure to Interrogate 214
Unable to Obtain Readings 194
Mechanical Problem 122
Appropriate Device Problem Term/Code Not Available 113
Premature Elective Replacement Indicator 88
Ambient Noise Problem 77

Yearly Trend

01
2001: 1
13
2013: 1
15
2015: 2
16
2016: 21
17
2017: 37
18
2018: 32
19
2019: 70
20
2020: 228
21
2021: 694
22
2022: 1,362
23
2023: 1,766
24
2024: 3,019
25
2025: 3,415
26
2026: 2,078

Reports rose to 3,415 in 2025, up from an average of 2,393 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

Top Manufacturers

MEDTRONIC SINGAPORE OPERATIONS 9,885
BIOTRONIK SE & CO. KG 1,467
BOSTON SCIENTIFIC CORPORATION 1,198
Medtronic Singapore Operations 73
MEDTRONIC, INC. 72
MEDTRONIC INC 7
Biotronik SE & Co. KG 4
MEDTRONIC 3
UNK 3

Event Locations

11,888 (93.4%)
I 825 (6.5%)
HOME 7 (0.1%)
HOSPITAL 3 (0.0%)
INVALID DATA 1 (0.0%)
NO INFORMATION 1 (0.0%)
OTHER 1 (0.0%)

Compare MEDTRONIC SINGAPORE OPERATIONS vs BIOTRONIK SE & CO. KG →

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 (12,726 here).

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 12,717 Shoulder Prosthesis, Reverse Configuration 12,771 Electrode, Ph, Stomach 12,853 Clamp, Vascular 12,982

Similar death-typed counts

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

Catheter, Urethral 4 Disinfectant, Medical Devices 4 Drill, Surgical, Ent Including Handpiece 4 Electrode 4

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.