FDA Adverse Event
Injury
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 5439706
·
Received February 16, 2016
Report
- Report Number
- 6000034-2016-00352
- Event Type
- Injury
- Date Received
- February 16, 2016
- Date of Event
- December 1, 2015
- Report Date
- April 12, 2016
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- P840024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED FEBRUARY 17, 2016.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED MAY 10, 2016.
Description of Event or Problem · 1
PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2015, DUE TO THE PATIENT REQUIRING REGULAR MRI SCANS. THERE ARE CURRENTLY NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, FEBRUARY 17, 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96286 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI22M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention |