MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · LWW
MAUDE profile for Pulse-Generator, Single Chamber, Single
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | LWW |
| Product code name | Pulse-Generator, Single Chamber, Single |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Premature Discharge of Battery, Over-Sensing, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, High impedance, Device Sensing Problem, Bradycardia 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