MAUDE manufacturer profile
GUIDANT PUERTO RICO BV · NVY
MAUDE profile for Permanent Defibrillator Electrodes
Key facts
| Manufacturer | GUIDANT PUERTO RICO BV |
|---|---|
| Manufacturer group | Boston Scientific Corporation |
| Product code | NVY |
| Product code name | Permanent Defibrillator Electrodes |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, High impedance, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Device Sensing Problem, Over-Sensing, Pacing Problem, Unspecified Infection 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