FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3250938
·
Received July 29, 2013
Report
- Report Number
- 6000034-2013-01377
- Event Type
- Injury
- Date Received
- July 29, 2013
- Date of Event
- July 17, 2013
- Report Date
- November 25, 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 CLINIC, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE ON (B)(6) 2013. THIS REPORT IS FILED (B)(4) 2013.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED FEBRUARY 13, 2014.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED (B)(6) 2013, IT IS UNKNOWN IF THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353992 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE MCM | MCM | COCHLEAR LTD. | CI24RE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Required Intervention |