FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
MDR report key: 2001719
·
Received February 25, 2011
Report
- Report Number
- 6000034-2011-00125
- Event Type
- Injury
- Date Received
- February 25, 2011
- Date of Event
- February 14, 2011
- Report Date
- August 6, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 000015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
CORRECTION: THE CORRECT BRAND NAME IS 'NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM'; NOT 'NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM' AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT PMA # IS 000015; NOT 970051 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED OCTOBER 1, 2013. IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A DECREMENT IN PERFORMANCE RESULTING IN DEVICE NON-USE. REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED, RESULTING IN DEVICE NON-USE. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | ABI24M | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |