MAUDE manufacturer profile
SORIN GROUP ITALIA S.R.L. - CRM FACILITY · NIK
MAUDE profile for Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Key facts
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
|---|---|
| Manufacturer group | SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUG |
| Product code | NIK |
| Product code name | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Information, No Known Impact Or Consequence To Patient, Over-Sensing, Adverse Event Without Identified Device or Use Problem, No Consequences Or Impact To Patient, Premature Discharge of Battery, High impedance, 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