MAUDE brand profile
PACESETTER
MAUDE brand safety profile
Key facts
| Brand name | PACESETTER |
|---|
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, Adverse Event Without Identified Device or Use Problem, Signal Artifact/Noise, Failure of Implant, No Clinical Signs, Symptoms or Conditions, Display or Visual Feedback Problem, Device Sensing Problem, Patient Device Interaction Problem Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1