MAUDE manufacturer profile
SORIN GROUP ITALIA S.R.L. - CRM FACILITY · NVZ
MAUDE profile for Pulse Generator, Permanent, Implantable
Key facts
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
|---|---|
| Manufacturer group | SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY |
| 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 Known Impact Or Consequence To Patient, No Information, Over-Sensing, No Pacing, Pacemaker Found in Back-Up Mode, High impedance, Adverse Event Without Identified Device or Use Problem, Premature Discharge of Battery 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