FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 708945
·
Received May 5, 2006
Report
- Report Number
- 6000034-2006-00157
- Event Type
- Injury
- Date Received
- May 5, 2006
- Date of Event
- April 4, 2006
- Report Date
- May 5, 2006
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PER THE SURGEON'S REPORT, THIS PATIENT DEVELOPED AN ABSCESS AT THE IMPLANT SITE. THE SURGEON EXPLANTED THE DEVICE ON 04/2006. PLANTS FOR REIMPLANTATION OF A NEW DEVICE WERE NOT REPORTED TO COCHLEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | CI24R(CS) | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Required Intervention |