FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2921056
·
Received January 17, 2013
Report
- Report Number
- 6000034-2013-00110
- Event Type
- Injury
- Date Received
- January 17, 2013
- Date of Event
- August 31, 2012
- Report Date
- March 11, 2013
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED (B)(4), 2013.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE ACCOMPANIED BY VERTIGO AND NAUSEA; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2012. THERE ARE NO PLANS TO REIMPLANT AS OF THE DATE OF THIS REPORT, (B)(6) 2013. THE MANUFACTURER BECAME AWARE UPON RECEIPT OF THE EXPLANTED DEVICE ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26133 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention |