FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 5849172
·
Received August 5, 2016
Report
- Report Number
- 6000034-2016-01438
- Event Type
- Injury
- Date Received
- August 5, 2016
- Date of Event
- July 11, 2016
- Report Date
- August 24, 2016
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED ON AUGUST 05, 2016. DEVICE NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED AUGUST 29, 2016.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED MIGRATION OF THE ELECTRODE ARRAY, RESULTING IN THE DECISION TO EXPLANT. THE DEVICE WAS EXPLANTED ON (B)(6) 2016. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT AUGUST 05, 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 501991 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI24R(ST) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Congenital Anomaly| R |