MAUDE manufacturer profile
CAMERON HEALTH · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | CAMERON HEALTH |
|---|---|
| Manufacturer group | CAMERON HEALTH |
| Product code | LWS |
| Product code name | Implantable Cardioverter Defibrillator (Non-Crt) |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Inappropriate/Inadequate Shock/Stimulation, No Consequences Or Impact To Patient, Over-Sensing, No Known Impact Or Consequence To Patient, Device Displays Incorrect Message, Unspecified Infection, Adverse Event Without Identified Device or Use Problem, 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