MAUDE manufacturer profile
SORIN CRM · MRM
MAUDE profile for Defibrillator, Implantable, Dual-Chamber
Key facts
| Manufacturer | SORIN CRM |
|---|---|
| Manufacturer group | SORIN CRM 98, RUE MAURICE ARNOUX 92120 MONTROUGE FRANCE |
| Product code | MRM |
| Product code name | Defibrillator, Implantable, Dual-Chamber |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Over-Sensing, No Information, No Consequences Or Impact To Patient, Inappropriate/Inadequate Shock/Stimulation, Display or Visual Feedback Problem, Impedance Problem, Failure to Interrogate 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