MAUDE manufacturer profile
SORIN GROUP ITALIA S.R.L. - CRM FACILITY · OSR
MAUDE profile for Pacemaker/Icd/Crt Non-Implanted Components
Key facts
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
|---|---|
| Manufacturer group | EOLANE |
| Product code | OSR |
| Product code name | Pacemaker/Icd/Crt Non-Implanted Components |
At a glance
- 100–999 MAUDE reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Communication or Transmission Problem, No Information, No Known Impact Or Consequence To Patient, Wireless Communication Problem, Data Problem, No Consequences Or Impact To Patient, Device Operates Differently Than Expected 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