Defibrillator, Implantable, Dual-Chamber
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 Defibrillator, Implantable, Dual-Chamber LIGHT-BOOK · MAUDE
#243 of 1000 · 7,651 reports · 2001–2026
- BOOK 7,651 reports
- RANK #243 of 1000
- DEATH 191 death-typed
- INJ 2,710 injury-typed
- MALF 4,632 malfunction
- SPAN 2001–2026
- PEAK 2010: 581
- PHOTO Device
Nearest event-volume peer: Device, Microtiter Diluting/Dispensing (56 report gap)
Defibrillator, Implantable, Dual-Chamber sits #243 of 1000 among tracked device types with 7,651 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 2.5% corpus 1.5% · above corpus mean (+1.0 pp)
- INJ 35.4% corpus 30.4% · above corpus mean (+5.0 pp)
- MALF 60.5% corpus 64.5% · below corpus mean (-4.0 pp)
Lead product-problem code Premature Elective Replacement Indicator is 31% of coded problems · Lead manufacturer BIOTRONIK SE & CO. KG accounts for 71% of manufacturer-tagged reports · Top event location is 46% of location-tagged rows .
Defibrillator, Implantable, Dual-Chamber in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Dermatome
Dermatome
7,806 reports
- System
System, Multipurpose For In Vitro Coagulation Studies
7,794 reports
- Device
Device, Microtiter Diluting/Dispensing
7,707 reports
- Defibrillator (this)
Defibrillator, Implantable, Dual-Chamber
7,651 reports
- Glucose Oxida…
Glucose Oxidase, Glucose
7,578 reports
- Hysteroscope
Hysteroscope (And Accessories)
7,561 reports
What this shows Defibrillator, Implantable, Dual-Chamber carries 7,651 MAUDE reports, ranked #243 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 Defibrillator, Implantable, Dual-Chamber
Top Manufacturers
Event Locations
Compare BIOTRONIK SE & CO. KG vs SORIN GROUP ITALIA S.R.L. - CRM FACILITY →
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Defibrillator, Implantable, Dual-Chamber, 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 (7,651 here).
Similar death-typed counts
Nearest other device types by death-typed report count (191 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Defibrillator, Implantable, Dual-Chamber 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 Defibrillator, Implantable, Dual-Chamber; 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.