FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 5457827
·
Received February 24, 2016
Report
- Report Number
- 6000034-2016-00344
- Event Type
- Injury
- Date Received
- February 24, 2016
- Date of Event
- February 2, 2016
- Report Date
- March 4, 2016
- Manufacturer
- COCHLEAR LTD .
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED FEBRUARY 24, 2016. THE DEVICE IS CURRENTLY UNAVAILABLE.
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED AS THE PATIENT REPORTED IT CAUSED THEM HEADACHES.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED (B)(6) 2016 FOR REASONS UNRELATED TO THE DEVICE. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, FEBRUARY 24, 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 112894 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD . | CI24M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |