MAUDE manufacturer profile
CPI PLANT - ST. PAUL · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | CPI PLANT - ST. PAUL |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | LWS |
| Product code name | Implantable Cardioverter Defibrillator (Non-Crt) |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Device Dislodged or Dislocated, Unspecified Infection, High impedance, Failure to Capture, Over-Sensing, Device Sensing 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