FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3081844
·
Received April 29, 2013
Report
- Report Number
- 6000034-2013-00754
- Event Type
- Injury
- Date Received
- April 29, 2013
- Date of Event
- April 8, 2013
- Report Date
- October 10, 2013
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
PER THE SURGEON, PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2013 FOR WOUND EXPLORATION. IT WAS DETERMINED THAT THE RECEIVER/STIMULATOR WAS VISIBLE THROUGH THE SKIN AND PATIENT HAD INFECTION AT IMPLANTED SITE. THE DEVICE WAS EXPLANTED AT THAT TIME ; REIMPLANTATION IS PLANNED, HOWEVER HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(4).
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED DECEMBER 12, 2013.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT DEVELOPED AN ABSCESS AROUND THE IMPLANT SITE. THE PATIENT WAS SEEN IN THE EMERGENCY ROOM ON (B)(6), 2013, TO RECEIVE UNREPORTED TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT, (B)(6), 2013. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185232 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD | CI24RE (CA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |