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 MAUDE casebook
openFDA event book Recorder, Event, Implantable Cardiac, MID-BOOK · MAUDE
#205 of 1000 · 10,606 reports · 2001–2026
- BOOK 10,606 reports
- RANK #205 of 1000
- DEATH 19 death-typed
- INJ 1,472 injury-typed
- MALF 9,112 malfunction
- SPAN 2001–2026
- PEAK 2018: 1,819
- PHOTO System
Nearest event-volume peer: System, Hemodynamic, Implantable (186 report gap)
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) sits #205 of 1000 among tracked device types with 10,606 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 →
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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 13.9% corpus 30.4% · below corpus mean (-16.6 pp)
- MALF 85.9% corpus 64.5% · above corpus mean (+21.4 pp)
Lead product-problem code Under-Sensing is 40% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC.(CRM-SYLMAR) accounts for 61% of manufacturer-tagged reports · Top event location I is 54% 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
- Compressor
Compressor, Cardiac, External
10,811 reports
- System
System, Hemodynamic, Implantable
10,792 reports
- Recorder (this)
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
10,606 reports
- System
System, Test, Automated Blood Grouping And Antibody
10,382 reports
- Appliance
Appliance, Fixation, Spinal Intervertebral Body
10,368 reports
- Ligator
Ligator, Esophageal
10,346 reports
What this shows Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) carries 10,606 MAUDE reports, ranked #205 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Related Entities for Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Top Manufacturers
Event Locations
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Recorder, Event, Implantable Cardiac,, 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 (10,606 here).
Similar death-typed counts
Nearest other device types by death-typed report count (19 here), distinct from the volume row.
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.