MAUDE manufacturer profile
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) · OJX
MAUDE profile for Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
Key facts
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Product code | OJX |
| Product code name | Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Device Dislodged or Dislocated, Failure to Capture, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, High Capture Threshold, Unspecified Infection, High impedance 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