FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2816261
·
Received November 2, 2012
Report
- Report Number
- 6000034-2012-02109
- Event Type
- Injury
- Date Received
- November 2, 2012
- Date of Event
- October 18, 2012
- Report Date
- December 17, 2013
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED DECEMBER 19, 2013.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, DEVICE WAS EXPLANTED ON (B)(6) 2012, DUE TO MENINGITIS. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT, 11/02/2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI24R (CA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Required Intervention |