MAUDE manufacturer profile
OSCOR INC · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | OSCOR INC |
|---|---|
| Manufacturer group | OSCOR INC |
| 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
- Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Signal Artifact/Noise, Electric Shock, Failure to Read Input Signal, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, High impedance 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