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 MAUDE casebook
openFDA event book Recorder, Event, Implantable Cardiac, MID-BOOK · MAUDE
#197 of 1000 · 11,120 reports · 2001–2026
- BOOK 11,120 reports
- RANK #197 of 1000
- DEATH 4 death-typed
- INJ 1,982 injury-typed
- MALF 9,134 malfunction
- SPAN 2001–2026
- PEAK 2025: 3,415
- PHOTO Dermal Cooling Pack/V…
Nearest event-volume peer: Dermal Cooling Pack/Vacuum/Massager (9 report gap)
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) sits #197 of 1000 among tracked device types with 11,120 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 17.8% corpus 30.4% · below corpus mean (-12.6 pp)
- MALF 82.1% corpus 64.5% · above corpus mean (+17.6 pp)
Lead product-problem code Reset Problem is 16% of coded problems · Lead manufacturer MEDTRONIC SINGAPORE OPERATIONS accounts for 79% 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
- Recorder (this)
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
11,120 reports
- Dermal Coolin…
Dermal Cooling Pack/Vacuum/Massager
11,111 reports
- Intracranial…
Intracranial Aneurysm Flow Diverter
11,101 reports
- Catheter
Catheter, Hemodialysis, Implanted
11,029 reports
- Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
10,969 reports
- Image-Intensi…
Image-Intensified Fluoroscopic X-Ray System, Mobile
10,959 reports
What this shows Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) carries 11,120 MAUDE reports, ranked #197 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, (With Arrhythmia Detection)
Top Manufacturers
Event Locations
Compare MEDTRONIC SINGAPORE OPERATIONS vs BIOTRONIK SE & CO. KG →
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 (11,120 here).
Similar death-typed counts
Nearest other device types by death-typed report count (4 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.