FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2001613
·
Received February 25, 2011
Report
- Report Number
- 6000034-2011-00117
- Event Type
- Injury
- Date Received
- February 25, 2011
- Date of Event
- September 23, 2010
- Report Date
- August 8, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- 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 SURGEON, THE DEVICE WAS EXPLANTED DUE TO INFECTION AND PARTIAL EXTRUSION OF THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(4), 2010. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(4), 2011.
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 | 78 YR | Required Intervention |