MAUDE manufacturer profile
ST. JUDE MEDICAL, COSTA RICA LTDA · DRF
MAUDE profile for Catheter, Electrode Recording, Or Probe, Electrode Recording
Key facts
| Manufacturer | ST. JUDE MEDICAL, COSTA RICA LTDA |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL, COSTA RICA LTDA |
| Product code | DRF |
| Product code name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Cardiac Perforation, No Consequences Or Impact To Patient, Difficult to Remove, Detachment of Device or Device Component, Vascular Dissection, Death, Material Deformation Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1