MAUDE manufacturer profile
IPG MFG SWITZERLAND · DSI
MAUDE profile for Detector And Alarm, Arrhythmia
Key facts
| Manufacturer | IPG MFG SWITZERLAND |
|---|---|
| Manufacturer group | MEDTRONIC CARDIAC RHYTHM HEART FAILURE |
| 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, Premature Discharge of Battery, Under-Sensing, Over-Sensing, Migration or Expulsion of Device, Failure to Interrogate, Unable to Obtain Readings, Adverse Event Without Identified Device or Use 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