FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 6062760
·
Received October 27, 2016
Report
- Report Number
- 6000034-2016-02208
- Event Type
- Injury
- Date Received
- October 27, 2016
- Date of Event
- October 17, 2016
- Report Date
- November 23, 2016
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502020268
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED ON OCTOBER 28, 2016. DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED POOR PERFORMANCE WITH DEVICE USE DUE TO PARTIAL INSERTION OF THE ELECTRODE ARRAY; SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2016 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 |
|---|---|---|---|---|---|---|---|
| 713693 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI422 | 09321502020268 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |