MAUDE manufacturer profile
HISTORICAL PUERTO RICO · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | HISTORICAL PUERTO RICO |
|---|---|
| Manufacturer group | HISTORICAL PUERTO RICO |
| Product code | LWS |
| Product code name | Implantable Cardioverter Defibrillator (Non-Crt) |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Unspecified Infection, Adverse Event Without Identified Device or Use Problem, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Over-Sensing, High impedance, Ambient Noise Problem, Fracture 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