FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 5976148
·
Received September 25, 2016
Report
- Report Number
- 6000034-2016-01826
- Event Type
- Injury
- Date Received
- September 25, 2016
- Report Date
- September 27, 2016
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502007320
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON SEPTEMBER 26, 2016 BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. CORRECTION: PER THE CLINIC, THE DEVICE WAS NOT EXPLANTED. THE IMPLANTED DEVICE REMAINS. THIS REPORT IS FILED OCTOBER 11, 2016. H3 OTHER TEXT: IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 0
PER THE CLINIC, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) DUE TO UNKNOWN REASON. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, SEPTEMBER 26, 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 627465 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI24RE (CA) | NA | 09321502007320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |