FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2160335
·
Received July 13, 2011
Report
- Report Number
- 6000034-2011-00452
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- October 30, 2010
- Report Date
- August 9, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED (B)(4), 2011.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO A SKIN FLAP INFECTION. THE DEVICE WAS EXPLANTED ON (B)(6) 2010. THE PATIENT WAS IMPLANTED ON (B)(6) 2011 WITH A NEW DEVICE IN THE CONTRALATERAL EAR.
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 (CS) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |