FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2393423
·
Received December 30, 2011
Report
- Report Number
- 6000034-2011-01363
- Event Type
- Injury
- Date Received
- December 30, 2011
- Date of Event
- December 2, 2011
- Report Date
- August 22, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE NOT AVAILABLE FOR ANALYSIS.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED ON SEPTEMBER 25, 2013.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT AND SUBSEQUENT LOSS OF BENEFIT. THE DEVICE WAS EXPLANTED (B)(6) 2011, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |