FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 4133907
·
Received October 2, 2014
Report
- Report Number
- 6000034-2014-01429
- Event Type
- Injury
- Date Received
- October 2, 2014
- Date of Event
- October 23, 2013
- Report Date
- September 10, 2014
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A TRAUMA AT THE IMPLANT SITE RESULTING IN MIGRATION OF THE RECEIVER STIMULATOR (SPECIFIC DATE NOT REPORTED). THE PATIENT UNDERWENT REVISION SURGERY TO REPOSITION THE DEVICE (SPECIFIC DATE NOT REPORTED), HOWEVER THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2013. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614446 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI24RE (ST) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Required Intervention |