System, Hemodynamic, Implantable
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 System, Hemodynamic, Implantable MID-BOOK · MAUDE
#204 of 1000 · 10,792 reports · 2015–2026
- BOOK 10,792 reports
- RANK #204 of 1000
- DEATH 225 death-typed
- INJ 3,907 injury-typed
- MALF 6,659 malfunction
- SPAN 2015–2026
- PEAK 2025: 2,236
- PHOTO Compressor
Nearest event-volume peer: Compressor, Cardiac, External (19 report gap)
System, Hemodynamic, Implantable sits #204 of 1000 among tracked device types with 10,792 MAUDE reports spanning 2015–2026. 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 2.1% corpus 1.5% · above corpus mean (+0.6 pp)
- INJ 36.2% corpus 30.4% · above corpus mean (+5.8 pp)
- MALF 61.7% corpus 64.5% · below corpus mean (-2.8 pp)
Lead product-problem code Material Frayed is 27% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC. accounts for 63% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .
System, Hemodynamic, Implantable in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- 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
- Compressor
Compressor, Cardiac, External
10,811 reports
- System (this)
System, Hemodynamic, Implantable
10,792 reports
- Recorder
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
10,606 reports
What this shows System, Hemodynamic, Implantable carries 10,792 MAUDE reports, ranked #204 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 System, Hemodynamic, Implantable
Top Manufacturers
Event Locations
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for System, Hemodynamic, Implantable, 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 (10,792 here).
Similar death-typed counts
Nearest other device types by death-typed report count (225 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for System, Hemodynamic, Implantable 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 System, Hemodynamic, Implantable; 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.