FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 3955134
·
Received July 24, 2014
Report
- Report Number
- 6000034-2014-01017
- Event Type
- Injury
- Date Received
- July 24, 2014
- Date of Event
- July 2, 2014
- Report Date
- October 10, 2014
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED OCTOBER 16TH, 2014.
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE IS CURRENTLY UNAVAILBLE.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT WAS EXPLANTED (B)(6) 2014 DUE TO PAIN AT THE IMPLANT SITE. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434570 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. | MCM | MCM | COCHLEAR LTD. | CI422 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |