MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · OSR
MAUDE profile for Pacemaker/Icd/Crt Non-Implanted Components
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | PLEXUS ELECTRONICA S DE RL DE CV |
| Product code | OSR |
| Product code name | Pacemaker/Icd/Crt Non-Implanted Components |
At a glance
- 1,000+ MAUDE reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Key or Button Unresponsive/not Working, Defective Device, Application Program Problem, Display or Visual Feedback Problem, Insufficient Information, Interrogation Problem, No Display/Image 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