MAUDE manufacturer profile
ABBOTT · LWP
MAUDE profile for Implantable Pulse Generator, Pacemaker (Non-Crt)
Key facts
| Manufacturer | ABBOTT |
|---|---|
| Manufacturer group | ABBOTT |
| Product code | LWP |
| Product code name | Implantable Pulse Generator, Pacemaker (Non-Crt) |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Failure to Interrogate, Premature Discharge of Battery, No Pacing, Over-Sensing, No Known Impact Or Consequence To Patient, Arrhythmia 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