MAUDE manufacturer profile
CPI PLANT - ST. PAUL · LWP
MAUDE profile for Implantable Pulse Generator, Pacemaker (Non-Crt)
Key facts
| Manufacturer | CPI PLANT - ST. PAUL |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | LWP |
| Product code name | Implantable Pulse Generator, Pacemaker (Non-Crt) |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Unspecified Infection, No Consequences Or Impact To Patient, Device Dislodged or Dislocated, No Known Impact Or Consequence To Patient, Material Integrity Problem, Capturing Problem, 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