MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · DTB
MAUDE profile for Permanent Pacemaker Electrode
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | CPI - DEL CARIBE |
| Product code | DTB |
| Product code name | Permanent Pacemaker Electrode |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Unspecified Infection, High impedance, Over-Sensing, High Capture Threshold, Signal Artifact/Noise, 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