FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 1970574
·
Received January 25, 2011
Report
- Report Number
- 6000034-2011-00046
- Event Type
- Injury
- Date Received
- January 25, 2011
- Date of Event
- December 10, 2010
- Report Date
- January 14, 2011
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PER THE CLINIC, THE ELECTRODE ARRAY WAS DISCOVERED TO BE IMPROPERLY PLACED IN THE COCHLEA. THE DEVICE WAS EXPLANTED (B)(6), 2010, 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. | MCM | MCM | COCHLEAR LTD | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |