FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 8329992
·
Received February 11, 2019
Report
- Report Number
- 6000034-2019-00181
- Event Type
- Injury
- Date Received
- February 11, 2019
- Date of Event
- October 29, 2018
- Report Date
- March 12, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502014564
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS FILED ON APRIL 05, 2019.
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON FEBRUARY 12, 2019, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). EXEMPTION NUMBER E2016011.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED NO AUDITORY STIMULATION WITH DEVICE USE AS A RESULT OF UNSUCCESSFUL INSERTION; SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2018 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118036 | NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI512 | N/A | 09321502014564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |