FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3235743
·
Received July 19, 2013
Report
- Report Number
- 6000034-2013-01316
- Event Type
- Injury
- Date Received
- July 19, 2013
- Date of Event
- July 10, 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
- KS
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED OCTOBER 25, 2013.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2013, DUE TO A SKIN FLAP INFECTION. THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336975 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI24RE (CA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |