FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3923799
·
Received July 9, 2014
Report
- Report Number
- 6000034-2014-00936
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- June 16, 2014
- Report Date
- July 28, 2014
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED JULY 31, 2014.
Additional Manufacturer Narrative · 1
(B)(4). DEVICE IS CURRENTLY UNAVAILABLE.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AND SKIN FLAP BREAKDOWN AT THE IMPLANT SITE REQUIRING TREATMENT WITH ORAL ANTIBIOTICS (DURATION NOT REPORTED). SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2014. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401030 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |