MAUDE manufacturer profile
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) · MXC
MAUDE profile for Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Key facts
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Product code | MXC |
| Product code name | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) |
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 Clinical Signs, Symptoms or Conditions, Under-Sensing, No Known Impact Or Consequence To Patient, Over-Sensing, Failure to Interrogate, Adverse Event Without Identified Device or Use Problem, Incorrect Measurement, Data 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