FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3041598
·
Received April 8, 2013
Report
- Report Number
- 6000034-2013-00603
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- August 1, 2012
- Report Date
- June 18, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PER THE SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2012, DUE TO EXTRUSION OF THE RECEIVER-STIMULATOR. DURING THE SAME SURGERY, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED FOR UNREPORTED REASONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT PROVIDED AS OF THE DATE OF THIS REPORT, (B)(4) 2013. THE DEVICE WAS EXPLANTED ON (B)(6) 2012. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143548 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI24RST |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Required Intervention |