MAUDE manufacturer profile
SORIN CRM · DXY
MAUDE profile for Implantable Pacemaker Pulse-Generator
Key facts
| Manufacturer | SORIN CRM |
|---|---|
| Manufacturer group | SORIN CRM |
| Product code | DXY |
| Product code name | Implantable Pacemaker Pulse-Generator |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 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, Unspecified Infection, Battery Problem: High Impedance, Death 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