MAUDE manufacturer profile
CPI - DEL CARIBE · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | CPI - DEL CARIBE |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | LWS |
| Product code name | Implantable Cardioverter Defibrillator (Non-Crt) |
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
- High impedance, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Over-Sensing, Unspecified Infection, Ambient Noise Problem, Capturing Problem 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