FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
MDR report key: 3240763
·
Received July 22, 2013
Report
- Report Number
- 6000034-2013-01355
- Event Type
- Injury
- Date Received
- July 22, 2013
- Date of Event
- July 17, 2013
- Report Date
- August 6, 2013
- Manufacturer
- COCHLEAR LTD .
- Product Code
- MCM
- PMA / PMN Number
- 00015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 WAS PLACED UNDER SEDATION TO PERFORM INITIAL ACTIVATION TESTING (EABR.). THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341483 | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD . | ABI 24M | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |