FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1781688
·
Received August 3, 2010
Report
- Report Number
- 6000034-2010-00510
- Event Type
- Injury
- Date Received
- August 3, 2010
- Date of Event
- July 6, 2010
- Report Date
- December 8, 2010
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED (B)(4) 2012.
Description of Event or Problem · 1
PER THE CLINIC, IT WAS REPORTED THAT THE DEVICE DID NOT ACHIEVE PROPER PLACEMENT IN THE COCHLEA DUE TO TEMPORAL BONE FRACTURES. IT WAS FURTHER REPORTED THAT THE IMPLANT ELECTRODE CURLED AT THE FRACTURE SITE. THE DEVICE WAS EXPLANTED ON (B)(6), 2010. IT IS UNKNOWN WHETHER THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Required Intervention |