MAUDE manufacturer profile
ST. JUDE MEDICAL, COSTA RICA LTDA (AFD) · OAE
MAUDE profile for Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Key facts
| Manufacturer | ST. JUDE MEDICAL, COSTA RICA LTDA (AFD) |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL, COSTA RICA LTDA |
| Product code | OAE |
| Product code name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Cardiac Perforation, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Communication or Transmission Problem, Optical Problem, Fracture, Impedance Problem, High impedance 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