MAUDE manufacturer profile
SORIN GROUP ITALIA S.R.L. - CRM FACILITY · KRG
MAUDE profile for Programmer, Pacemaker
Key facts
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
|---|---|
| Manufacturer group | KONTRON |
| Product code | KRG |
| Product code name | Programmer, Pacemaker |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Information, Device Operates Differently Than Expected, No Consequences Or Impact To Patient, No Patient Involvement, No Clinical Signs, Symptoms or Conditions, Application Interface Becomes Non-Functional Or Program Exits Abnormally, Interrogation 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