FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
MDR report key: 3935977
·
Received July 15, 2014
Report
- Report Number
- 6000034-2014-00966
- Event Type
- Injury
- Date Received
- July 15, 2014
- Date of Event
- June 23, 2014
- Report Date
- September 9, 2014
- Manufacturer
- COCHLEAR LTD .
- Product Code
- MCM
- PMA / PMN Number
- 000015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS REPORT FILED SEPTEMBER 12, 2014.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014 TO REPOSITION THE DEVICE. THE PROCEDURE WAS UNSUCCESSFUL. DURING THE SAME PROCEDURE THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS REIMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414112 | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD . | ABI24M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |