FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 5668918
·
Received May 20, 2016
Report
- Report Number
- 6000034-2016-01084
- Event Type
- Injury
- Date Received
- May 20, 2016
- Date of Event
- April 11, 2016
- Report Date
- June 29, 2016
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED ON MAY 20, 2016.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION OF THE SKIN FLAP, HOWEVER THE ISSUE COULD NOT BE RESOLVED; SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2016. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT, MAY 20, 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323851 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI24RE (CA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |