FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2954744
·
Received February 11, 2013
Report
- Report Number
- 6000034-2013-00285
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- February 4, 2013
- Report Date
- August 21, 2013
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER THE PATIENT'S SURGEON, 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. THIS REPORT IS FILED (B)(4) 2013.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES FOLLOWED BY A COMPLETE LOSS OF CONNECTION TO THE INTERNAL DEVICE SUBSEQUENT TO SUSTAINING A HEAD TRAUMA. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, FEBRUARY 11, 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59092 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Required Intervention |