FDA Adverse Event
Injury
Summary report: N
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 12363909
·
Received August 25, 2021
Report
- Report Number
- 6000034-2021-02575
- Event Type
- Injury
- Date Received
- August 25, 2021
- Date of Event
- August 3, 2021
- Report Date
- August 5, 2021
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON AUGUST 25, 2021.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT WAS PLACED UNDER SEDATION ON (B)(6) 2021 IN ORDER TO UNDERGO MRI DUE TO SEVERE PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1262313 | NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24RE (CA) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |