MAUDE manufacturer profile
MEDTRONIC SINGAPORE OPERATIONS · DXY
MAUDE profile for Implantable Pacemaker Pulse-Generator
Key facts
| Manufacturer | MEDTRONIC SINGAPORE OPERATIONS |
|---|---|
| Manufacturer group | MEDTRONIC SINGAPORE OPERATIONS |
| Product code | DXY |
| Product code name | Implantable Pacemaker Pulse-Generator |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Premature Discharge of Battery, No Known Impact Or Consequence To Patient, Mechanical Problem, Pacing Problem, No Consequences Or Impact To Patient, Syncope, Cardiac Arrest 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