FDA Adverse Event
Injury
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3233243
·
Received July 18, 2013
Report
- Report Number
- 6000034-2013-01296
- Event Type
- Injury
- Date Received
- July 18, 2013
- Date of Event
- June 6, 2013
- Report Date
- November 25, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER CAREGIVERS
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED NOVEMBER 29, 2013.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH DEVICE USE; HOWEVER THE ISSUE COULD NOT BE RESOLVED.THE DEVICE WAS EXPLANTED ON (B)(6), 2013, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334481 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI22M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention |