FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 15965476
·
Received December 12, 2022
Report
- Report Number
- 6000034-2022-03754
- Event Type
- Malfunction
- Date Received
- December 12, 2022
- Date of Event
- September 8, 2022
- Report Date
- February 21, 2023
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502007320
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON DECEMBER 13, 2022
Additional Manufacturer Narrative · 0
CORRECTION: THE PREVIOUS MDRS SUBMITTED ON DECEMBER 13, 2022 WERE FILED INADVERTENTLY. NO EXTRUSION HAS OCCURRED. THIS REPORT IS SUBMITTED ON JANUARY 20, 2023.
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON MARCH 31, 2023.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT SUSTAINED A HEAD INJURY RESULTING IN AN EXTRUSION OF THE RECEIVER/STIMULATOR. THE DEVICE WAS EXPLANTED ON (B)(6) 2022. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT WITH ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2182020 | NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24RE (CA) | N/A | 09321502007320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Male | Required Intervention |