MAUDE manufacturer profile
MEDTRONIC PUERTO RICO OPERATIONS CO. · NIK
MAUDE profile for Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Key facts
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
|---|---|
| Manufacturer group | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Product code | NIK |
| Product code name | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Unspecified Infection, Premature Discharge of Battery, No Clinical Signs, Symptoms or Conditions, Shock from Patient Lead(s), Inappropriate/Inadequate Shock/Stimulation, Device Sensing 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