FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
MDR report key: 10268889
·
Received July 13, 2020
Report
- Report Number
- 6000034-2020-01765
- Event Type
- Malfunction
- Date Received
- July 13, 2020
- Date of Event
- June 19, 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
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON OCTOBER16, 2020.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JULY 14, 2020.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2020, DUE TO THE DEVICE PROTRUDING. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR IMPLANT DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726571 | NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI422 | NA | 09321502025706 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Required Intervention |