MAUDE manufacturer profile
ST. JUDE MEDICAL, INC. - CARDIOMEMS · MOM
MAUDE profile for System, Hemodynamic, Implantable
Key facts
| Manufacturer | ST. JUDE MEDICAL, INC. - CARDIOMEMS |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL, INC. - CARDIOMEMS |
| Product code | MOM |
| Product code name | System, Hemodynamic, Implantable |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Device Displays Incorrect Message, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Device Sensing Problem, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Application Program Problem, Hemoptysis 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