MAUDE manufacturer profile
MEDTRONIC EUROPE SARL · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | MEDTRONIC EUROPE SARL |
|---|---|
| Manufacturer group | MEDTRONIC EUROPE SARL |
| Product code | LWS |
| Product code name | Implantable Cardioverter Defibrillator (Non-Crt) |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Device Sensing Problem, Adverse Event Without Identified Device or Use Problem, Shock from Patient Lead(s), Inappropriate/Inadequate Shock/Stimulation, Unspecified Infection, Premature Discharge of Battery, No Known Impact Or Consequence To Patient 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