MAUDE manufacturer profile
SORIN CRM S.A.S · NVZ
MAUDE profile for Pulse Generator, Permanent, Implantable
Key facts
| Manufacturer | SORIN CRM S.A.S |
|---|---|
| Manufacturer group | SORIN CRM 98, RUE MAURICE ARNOUX 92120 MONTROUGE F |
| Product code | NVZ |
| Product code name | Pulse Generator, Permanent, Implantable |
At a glance
- 1,000+ MAUDE reports
- 10–99 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, Premature Elective Replacement Indicator, Premature Discharge of Battery, Pacemaker Found in Back-Up Mode, No Clinical Signs, Symptoms or Conditions, Failure to Interrogate, Battery Problem: High Impedance 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