FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24
MDR report key: 8388618
·
Received March 4, 2019
Report
- Report Number
- 6000034-2019-00307
- Event Type
- Injury
- Date Received
- March 4, 2019
- Report Date
- February 18, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON MARCH 05, 2019.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2018 DUE TO MIGRATION OF THE ELECTRODE ARRAY. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180565 | NUCLEUS 24 | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24M | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |