MAUDE manufacturer profile
GUIDANT CRM CLONMEL IRELAND · DXY
MAUDE profile for Implantable Pacemaker Pulse-Generator
Key facts
| Manufacturer | GUIDANT CRM CLONMEL IRELAND |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | DXY |
| Product code name | Implantable Pacemaker Pulse-Generator |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Device Displays Incorrect Message, Unspecified Infection, Adverse Event Without Identified Device or Use Problem, High impedance, Failure to Capture, Over-Sensing, Pacing Problem 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