MAUDE brand profile
FORTIFY ASSURA VR ICD US
MAUDE brand safety profile
Key facts
| Brand name | FORTIFY ASSURA VR ICD US |
|---|
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Premature Discharge of Battery, Battery Problem, Over-Sensing, Inappropriate or Unexpected Reset, Inappropriate/Inadequate Shock/Stimulation 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