MAUDE manufacturer profile
MEDTRONIC IRELAND · DXY
MAUDE profile for Implantable Pacemaker Pulse-Generator
Key facts
| Manufacturer | MEDTRONIC IRELAND |
|---|---|
| Manufacturer group | MEDTRONIC IRELAND |
| Product code | DXY |
| Product code name | Implantable Pacemaker Pulse-Generator |
At a glance
- 1–9 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, High Capture Threshold, Adverse Event Without Identified Device or Use Problem, Positioning Problem, Premature Discharge of Battery, Unstable Capture Threshold, Cardiac Tamponade, Cardiac Perforation 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