FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1930666
·
Received December 16, 2010
Report
- Report Number
- 6000034-2010-00796
- Event Type
- Injury
- Date Received
- December 16, 2010
- Date of Event
- January 1, 2010
- Report Date
- March 29, 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 EXPLANTED DUE TO THE ELECTRODE ARRAY NOT BEING FOUND TO BE PROPERLY LOCATED IN THE COCHLEA. THE DEVICE WAS EXPLANTED ON IN (B)(6), 2010 (DATE NOT SPECIFED). THERE ARE NO PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT, (B)(6), 2010.
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. | CI24R (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Required Intervention |