FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 2981754
·
Received February 27, 2013
Report
- Report Number
- 6000034-2013-00313
- Event Type
- Injury
- Date Received
- February 27, 2013
- Date of Event
- January 3, 2013
- Report Date
- February 7, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LACK OF AUDITORY BENEFIT WITH DEVICE USE. A CT SCAN (DATE NOT REPORTED) INDICATED EXTRACOCHLEAR ELECTRODE ARRAY PLACEMENT.THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013, TO REPOSITION THE ELECTRODE ARRAY. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83768 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. | MCM | MCM | COCHLEAR LTD. | CI512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |