FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
MDR report key: 10031583
·
Received May 7, 2020
Report
- Report Number
- 6000034-2020-01288
- Event Type
- Injury
- Date Received
- May 7, 2020
- Report Date
- September 25, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502025706
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE ANALYSIS REPORT IS ATTACHED. THIS REPORT IS SUBMITTED ON OCTOBER 16, 2020.
Additional Manufacturer Narrative · 0
THE DATE OF AWARENESS FOR THE INITIAL REPORT IS APRIL 16, 2020. THIS REPORT IS SUBMITTED ON MAY 26, 2020.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) DUE TO EXTRUSION OF DEVICE. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE (DATE NOT REPORTED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 498337 | NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI422 | N/A | 09321502025706 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |