FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
MDR report key: 11713886
·
Received April 23, 2021
Report
- Report Number
- 6000034-2021-01363
- Event Type
- Injury
- Date Received
- April 23, 2021
- Date of Event
- March 13, 2020
- Report Date
- March 13, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502036573
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON APRIL 23, 2021.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020, IN ORDER TO PLACE AN IMPLANT MAGNET. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 616148 | NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI622 | NA | 09321502036573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Required Intervention |