MAUDE manufacturer profile
CPI - DEL CARIBE · LWP
MAUDE profile for Implantable Pulse Generator, Pacemaker (Non-Crt)
Key facts
| Manufacturer | CPI - DEL CARIBE |
|---|---|
| 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
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Material Integrity Problem, Adverse Event Without Identified Device or Use Problem, Device Dislodged or Dislocated, No Known Impact Or Consequence To Patient, Unspecified Infection, 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