MAUDE manufacturer profile
SPECTRANETICS CORPORATION · MFA
MAUDE profile for Device, Removal, Pacemaker Electrode, Percutaneous
Key facts
| Manufacturer | SPECTRANETICS CORPORATION |
|---|---|
| Manufacturer group | SPECTRANETICS CORPORATION |
| Product code | MFA |
| Product code name | Device, Removal, Pacemaker Electrode, Percutaneous |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death 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, Great Vessel Perforation, Iatrogenic Source, Perforation of Vessels, Death, Low Blood Pressure/ Hypotension, Pericardial Effusion, Injury 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