MAUDE brand profile
ELLIPSE DR ICD US
MAUDE brand safety profile
Key facts
| Brand name | ELLIPSE DR ICD US |
|---|
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Over-Sensing, No Known Impact Or Consequence To Patient, Inappropriate or Unexpected Reset, Inappropriate/Inadequate Shock/Stimulation, Environmental Compatibility Problem, Pacing Problem, Incorrect Interpretation of Signal Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1