MAUDE manufacturer profile
MEDTRONIC EUROPE SARL · DSI
MAUDE profile for Detector And Alarm, Arrhythmia
Key facts
| Manufacturer | MEDTRONIC EUROPE SARL |
|---|---|
| Manufacturer group | MEDTRONIC EUROPE SARL |
| Product code | DSI |
| Product code name | Detector And Alarm, Arrhythmia |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Under-Sensing, Over-Sensing, No Clinical Signs, Symptoms or Conditions, Signal Artifact/Noise, Device Sensing Problem, No Consequences Or Impact To Patient, 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