FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3822282
·
Received May 20, 2014
Report
- Report Number
- 6000034-2014-00690
- Event Type
- Injury
- Date Received
- May 20, 2014
- Date of Event
- March 8, 2014
- Report Date
- May 26, 2014
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED JUNE 4, 2014.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE AUDIOLOGIST, THE PATIENT EXPERIENCED NON-AUDITORY STIMULATION AND A PERFORMANCE DECREMENT WITH DEVICE USE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2014, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300641 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI24RE (ST) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |