FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 5849162
·
Received August 5, 2016
Report
- Report Number
- 6000034-2016-01614
- Event Type
- Injury
- Date Received
- August 5, 2016
- Date of Event
- July 28, 2016
- Report Date
- September 16, 2016
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- AUDIOLOGIST
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 OCTOBER 10, 2016.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH DEVICE USE, HOWEVER, THE ISSUE DID NOT RESOLVE; SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2016. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT 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 |
|---|---|---|---|---|---|---|---|
| 501894 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI422 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |