FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2905586
·
Received January 9, 2013
Report
- Report Number
- 6000034-2013-00024
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- December 17, 2012
- Report Date
- July 2, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED ON AUGUST 21, 2013.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED ABNORMAL SOUND QUALITY AND SUBSEQUENT PERFORMANCE DECREMENT. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED (B)(6) 2012, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12270 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI24RE (CA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention |