FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3139234
·
Received May 31, 2013
Report
- Report Number
- 6000034-2013-00993
- Event Type
- Injury
- Date Received
- May 31, 2013
- Date of Event
- April 24, 2013
- Report Date
- October 23, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO MIGRATION OF THE IMPLANT BODY. THIS REPORT IS FILED OCTOBER 25, 2013.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2013 FOR UNSPECIFIC REASONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241901 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI24RE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 MO | Required Intervention |