MAUDE manufacturer profile
ST. JUDE MEDICAL, INC., CRMD · DXY
MAUDE profile for Implantable Pacemaker Pulse-Generator
Key facts
| Manufacturer | ST. JUDE MEDICAL, INC., CRMD |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL, INC., CRMD |
| Product code | DXY |
| Product code name | Implantable Pacemaker Pulse-Generator |
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
- No Known Impact Or Consequence To Patient, Difficult to Insert, Pacemaker Found in Back-Up Mode, Adverse Event Without Identified Device or Use Problem, No Patient Involvement, Unspecified Infection, Over-Sensing, Device Operates Differently Than Expected 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