FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
MDR report key: 8710516
·
Received June 18, 2019
Report
- Report Number
- 6000034-2019-00988
- Event Type
- Injury
- Date Received
- June 18, 2019
- Date of Event
- May 27, 2019
- Report Date
- June 25, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502032599
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS FILED ON JULY 12, 2019.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JUNE 19, 2019.
Description of Event or Problem · 1
THE PATIENT EXPERIENCED BREAKDOWN OF THE SKINFLAP AT IMPLANT SITE RESULTING IN EXTRUSION OF DEVICE; SUBSEQUENTLY THE PATIENT UNDERWENT SKIN FLAP REVISION SURGERY TO EXPLANT THE RECEIVER-STIMULATOR, THE ELECTRODE ARRAY REMAINS IN-SITU. REIMPLANTATION HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT ON JUNE 19, 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499732 | 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 | 5 YR | Required Intervention |