FDA Adverse Event
Injury
Summary report: N
NUCLUES 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 611812
·
Received June 8, 2005
Report
- Report Number
- 6000034-2005-00155
- Event Type
- Injury
- Date Received
- June 8, 2005
- Date of Event
- August 7, 2003
- Report Date
- June 8, 2005
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
COCHLEAR AMERICAS WAS NOTIFIED IN 06/2005 THAT A COCHLEAR IMPLANT RECIPIENT CONTACTED MENINGITIS, POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLUES 24 CHANNEL COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | C124M | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Hospitalization| R |