MAUDE manufacturer profile
GUIDANT ANGLETON/ST. PAUL · DTB
MAUDE profile for Permanent Pacemaker Electrode
Key facts
| Manufacturer | GUIDANT ANGLETON/ST. PAUL |
|---|---|
| Manufacturer group | GUIDANT ANGLETON/ST. PAUL |
| Product code | DTB |
| Product code name | Permanent Pacemaker Electrode |
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 Consequences Or Impact To Patient, Material Integrity Problem, Unspecified Infection, Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Connection Problem, Ambient Noise Problem, Low 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