FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3971841
·
Received July 31, 2014
Report
- Report Number
- 6000034-2014-01071
- Event Type
- Injury
- Date Received
- July 31, 2014
- Date of Event
- July 4, 2014
- Report Date
- July 11, 2014
- Manufacturer
- COCHLEAR LTD .
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE IS CURRENTLY UNAVAILABLE.
Description of Event or Problem · 1
PER THE AUDIOLOGIST, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH DEVICE USE. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL IN ALLEVIATING THE ISSUE. IMAGING REVEALED THAT THE ELECTRODE ARRAY WAS OUTSIDE OF THE COCHLEA. THE DEVICE WAS EXPLANTED ON (B)(6) 2014, AND THE PATIENT REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 446938 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD . | CI422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Required Intervention |