MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · MXD
MAUDE profile for Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | MXD |
| Product code name | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Wound Dehiscence, Premature Discharge of Battery, Unspecified Infection, Erosion, Communication or Transmission Problem, Migration 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