MAUDE manufacturer profile
SORIN GROUP ITALIA S.R.L. - CRM FACILITY · LWS
MAUDE profile for Implantable Cardioverter Defibrillator (Non-Crt)
Key facts
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
|---|---|
| Manufacturer group | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
| 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
- No Known Impact Or Consequence To Patient, No Information, Over-Sensing, Adverse Event Without Identified Device or Use Problem, Wireless Communication Problem, No Consequences Or Impact To Patient, Premature Discharge of Battery, Inappropriate/Inadequate Shock/Stimulation 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