MAUDE manufacturer profile
OSYPKA MEDICAL GMBH · DTE
MAUDE profile for Pulse-Generator, Pacemaker, External
Key facts
| Manufacturer | OSYPKA MEDICAL GMBH |
|---|---|
| Manufacturer group | OSYPKA MEDICAL GMBH |
| Product code | DTE |
| Product code name | Pulse-Generator, Pacemaker, External |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, No Pacing, Adverse Event Without Identified Device or Use Problem, Failure to Sense, Cardiac Arrest, Unexpected Shutdown, Asystole 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