FDA Adverse Event
Injury
Summary report: N
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 12859003
·
Received November 23, 2021
Report
- Report Number
- 6000034-2021-03597
- Event Type
- Injury
- Date Received
- November 23, 2021
- Report Date
- November 4, 2021
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502007320
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON NOVEMBER 23, 2021.
Description of Event or Problem · 0
PER THE CLINIC, IT WAS REPORTED THAT IMPLANT SITE (AROUND THE IMPLANT COIL) WAS INFLATED WITH AIR AND SUBSEQUENTLY, THE AIR WAS RELEASED FROM THE SURGICAL SITE USING A SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1757137 | NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24RE (CA) | NA | 09321502007320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |