MAUDE manufacturer profile
MEDTRONIC MED REL MEDTRONIC PUERTO RICO · DSI
MAUDE profile for Detector And Alarm, Arrhythmia
Key facts
| Manufacturer | MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
|---|---|
| Manufacturer group | MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
| Product code | DSI |
| Product code name | Detector And Alarm, Arrhythmia |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Under-Sensing, Over-Sensing, Battery Problem, Failure to Interrogate, Pain, Adverse Event Without Identified Device or Use Problem, 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