FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1833928
·
Received September 14, 2010
Report
- Report Number
- 6000034-2010-00608
- Event Type
- Injury
- Date Received
- September 14, 2010
- Date of Event
- September 8, 2010
- Report Date
- March 10, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO MIGRATION OF THE ELECTRODE ARRAY. THE SURGEON EXPLANTED THE DEVICE AND DETERMINED THAT REIMPLANTATION COULD NOT BE SUCCESSFULLY ACHIEVED. IMPLANTATION IN THE CONTRALATERAL EAR IS BEING CONSIDERED BUT HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |