FDA Adverse Event
Injury
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 3953977
·
Received July 23, 2014
Report
- Report Number
- 6000034-2014-10174
- Event Type
- Injury
- Date Received
- July 23, 2014
- Date of Event
- June 12, 2014
- Report Date
- July 4, 2014
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 840024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2014 DUE TO THE NEED FOR MRI'S RELATED TO OTHER HEALTH CONDITIONS NOT ASSOCIATED WITH THE COCHLEAR IMPLANT. DURING THE SAME SURGERY, THE PATIENT WAS REIMPLANTED WITH ANOTHER MANUFACTURER'S DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431360 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM. | MCM: PRODUCT CODE | MCM | COCHLEAR LTD. | CI22M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |