FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 14984085
·
Received July 12, 2022
Report
- Report Number
- 6000034-2022-02043
- Event Type
- Injury
- Date Received
- July 12, 2022
- Date of Event
- June 9, 2022
- Report Date
- June 22, 2022
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502014564
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE ANALYSIS REPORT ATTACHED. THIS REPORT IS SUBMITTED ON (B)(6) 2022.
Description of Event or Problem · 0
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON JUNE 09, 2022, DUE TO CHOLESTEATOMA. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1049154 | NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI512 | NA | 09321502014564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Male | Required Intervention |