FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24K
MDR report key: 10045873
·
Received May 11, 2020
Report
- Report Number
- 6000034-2020-01256
- Event Type
- Injury
- Date Received
- May 11, 2020
- Report Date
- April 23, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON MAY 12 2020.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT UNDERWENT SKIN FLAP REDUCTION SURGERY FOR UNKNOWN REASONS (DATE NOT REPORTED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509426 | NUCLEUS 24K | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24R (ST) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |