MAUDE manufacturer profile
IPG MFG SWITZERLAND · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | IPG MFG SWITZERLAND |
|---|---|
| Manufacturer group | MEDTRONIC CARDIAC RHYTHM HEART FAILURE |
| 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
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Premature Discharge of Battery, Mechanical Problem, Invalid Sensing, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Shock from Patient Lead(s), Adverse Event Without Identified Device or Use 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