FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1901674
·
Received November 17, 2010
Report
- Report Number
- 6000034-2010-00708
- Event Type
- Injury
- Date Received
- November 17, 2010
- Date of Event
- August 11, 2010
- Report Date
- May 20, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- 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 PARTIALLY INSERTED IN THE COCHLEA DURING THE INITIAL IMPLANTATION. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN WITH STIMULATION, FACIAL NERVE STIMULATION, AND HEADACHES. THE DEVICE WAS EXPLANTED DUE TO ELECTRODE ARRAY EXTRUSION ON (B)(6) 2010 AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention |