MAUDE manufacturer profile
CPI PLANT - ST. PAUL · DTB
MAUDE profile for Permanent Pacemaker Electrode
Key facts
| Manufacturer | CPI PLANT - ST. PAUL |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | DTB |
| Product code name | Permanent Pacemaker Electrode |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, High impedance, Capturing Problem, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem, Material Integrity Problem, Unspecified Infection, Failure to Capture 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