MAUDE manufacturer profile
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) · PNJ
MAUDE profile for Leadless Pacemaker
Key facts
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Product code | PNJ |
| Product code name | Leadless Pacemaker |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Stretched, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem, Pericardial Effusion, Embolism/Embolus, Cardiac Perforation, Failure to Capture 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