FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 8665339
·
Received June 4, 2019
Report
- Report Number
- 6000034-2019-00955
- Event Type
- Malfunction
- Date Received
- June 4, 2019
- Date of Event
- April 24, 2019
- Report Date
- August 13, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502014564
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE ANALYSIS INDICATES A DEVICE FAILURE THIS REPORT IS SUBMITTED ON SEPTEMBER 04, 2019.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JUNE 04, 2019.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXPLANTED ON (B)(6) 2019 DUE TO LOSS OF ELECTRODE FUNCTION. THE RECIPIENT WAS RE-IMPLANTED WITH A NEW DEVICE AT THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462789 | NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI512 | NI | 09321502014564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Required Intervention |