MAUDE brand profile
PLEXA PROMRI DF1 S DX 6515
MAUDE brand safety profile
Key facts
| Brand name | PLEXA PROMRI DF1 S DX 6515 |
|---|
At a glance
- 1,000+ MAUDE reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Ambient Noise Problem, Over-Sensing, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Inappropriate/Inadequate Shock/Stimulation, Shock from Patient Lead(s), Unspecified Infection 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