FDA Adverse Event
Injury
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3122985
·
Received May 21, 2013
Report
- Report Number
- 6000034-2013-00927
- Event Type
- Injury
- Date Received
- May 21, 2013
- Date of Event
- May 6, 2013
- Report Date
- October 10, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 840024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED DECEMBER 12, 2013.
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE EXPLANT SURGERY ON (B)(6) 2013. EXPLANT AND REIMPLANT SURGERY PERFORMED BECAUSE THE PATIENT WAS NOT RECEIVING BENEFIT WITH USE OF THE DEVICE. THIS REPORT IS FILED (B)(4) 2013.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED (B)(6) 2013, FOR UNKNOWN REASONS. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 225123 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI22M | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |