MAUDE manufacturer profile
ABBOTT · OSR
MAUDE profile for Pacemaker/Icd/Crt Non-Implanted Components
Key facts
| Manufacturer | ABBOTT |
|---|---|
| Manufacturer group | ABBOTT |
| Product code | OSR |
| Product code name | Pacemaker/Icd/Crt Non-Implanted Components |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Incorrect Measurement, Application Program Freezes, Becomes Nonfunctional, Arrhythmia, Program or Algorithm Execution Failure, Program or Algorithm Execution Problem, Key or Button Unresponsive/not Working, Loose or Intermittent Connection 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