FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
MDR report key: 8763092
·
Received July 5, 2019
Report
- Report Number
- 6000034-2019-01098
- Event Type
- Injury
- Date Received
- July 5, 2019
- Date of Event
- April 3, 2019
- Report Date
- June 17, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502032599
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JULY 05, 2019.
Description of Event or Problem · 1
THE RECIPIENT EXPERIENCED BREAKDOWN OF THE SKINFLAP AND INFECTION AT THE IMPLANT SIDE (INITIALLY TREATED WITH IV ANTIBIOTICS), RESULTING IN EXTRUSION OF THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2019. THE CLINIC REPORTED THAT FOLLOWING REMOVAL EVERYTHING HAS HEALED NICELY AND THE RECIPIENT WAS IMPLANTED ON THE OTHER SIDE 4 WEEKS LATER WITH NO PROBLEMS SINCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 558100 | NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI522 | NI | 09321502032599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |