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
#249 of 1000 · 7,836 reports · 2001–2026
- BOOK 7,836 reports
- RANK #249 of 1000
- DEATH 191 death-typed
- INJ 2,812 injury-typed
- MALF 4,715 malfunction
- SPAN 2001–2026
- PEAK 2010: 581
- PHOTO Intracranial Neurovas…
Nearest event-volume peer: Intracranial Neurovascular Stent (4 report gap)
Defibrillator, Implantable, Dual-Chamber sits #249 of 1000 among tracked device types with 7,836 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 →
Injury-coded reports run above the device-type norm
Defibrillator, Implantable, Dual-Chamber carries 35.9% INJURY-coded reports, 5.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 2.4% corpus 1.5% · above corpus mean (+0.9 pp)
- INJ 35.9% corpus 30.3% · above corpus mean (+5.6 pp)
- MALF 60.2% corpus 64.8% · below corpus mean (-4.7 pp)
Lead product-problem code Premature Elective Replacement Indicator is 21% of coded problems · Lead manufacturer BIOTRONIK SE & CO. KG accounts for 71% of manufacturer-tagged reports · Top event location is 47% 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
- Catheter
Catheter, Ultrasound, Intravascular
7,853 reports
- Intracranial…
Intracranial Neurovascular Stent
7,840 reports
- Defibrillator (this)
Defibrillator, Implantable, Dual-Chamber
7,836 reports
- System
System, Multipurpose For In Vitro Coagulation Studies
7,801 reports
- Catheter
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
7,737 reports
- Catheter
Catheter, Embolectomy
7,736 reports
What this shows Defibrillator, Implantable, Dual-Chamber carries 7,836 MAUDE reports, ranked #249 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
Reports in 2025 (454) held close to the prior two-year average of 533.
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 a comparable volume-and-death footprint
Two openFDA-derived peer sets for Defibrillator, Implantable, Dual-Chamber: 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 (7,836 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.