FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2466182
·
Received February 23, 2012
Report
- Report Number
- 6000034-2012-00330
- Event Type
- Injury
- Date Received
- February 23, 2012
- Date of Event
- December 20, 2011
- Report Date
- June 13, 2012
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED APRIL 14, 2014.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2011 DUE TO POOR PERFORMANCE. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, FEBRUARY 23, 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention |