MAUDE manufacturer profile
MEDTRONIC PUERTO RICO OPERATIONS CO. · NKE
MAUDE profile for Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Key facts
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
|---|---|
| Manufacturer group | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Product code | NKE |
| Product code name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Unspecified Infection, Premature Discharge of Battery, Unable to Obtain Readings, Inappropriate or Unexpected Reset, Reset Problem 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