MAUDE manufacturer profile
ABBOTT MEDICAL · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | ABBOTT MEDICAL |
|---|---|
| Manufacturer group | ABBOTT MEDICAL |
| Product code | LWS |
| Product code name | Implantable Cardioverter Defibrillator (Non-Crt) |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, No Clinical Signs, Symptoms or Conditions, Over-Sensing, Impedance Problem, Output Problem, High impedance, Adverse Event Without Identified Device or Use Problem, Low 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