FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3013635
·
Received March 20, 2013
Report
- Report Number
- 6000034-2013-00540
- Event Type
- Injury
- Date Received
- March 20, 2013
- Report Date
- October 3, 2013
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED DECEMBER 11, 2013. DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED EXTRUSION OF THE ELECTRODE ARRAY FROM THE COCHLEAR AND AUDITORY CANAL (DATE NOT REPORTED). THE DEVICE WAS EXPLANTED ON (B)(6) 2013, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115525 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI24RE (CA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |