MAUDE brand profile
AFFINITY SR
MAUDE brand safety profile
Key facts
| Brand name | AFFINITY SR |
|---|
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Pacemaker Found in Back-Up Mode, Device Operates Differently Than Expected, Muscle Stimulation, Adverse Event Without Identified Device or Use Problem, Failure to Sense, Premature Discharge of Battery, Incorrect Measurement 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