FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3091029
·
Received May 3, 2013
Report
- Report Number
- 6000034-2013-00792
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- April 16, 2013
- Report Date
- November 5, 2013
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED NOVEMBER 11, 2013.
Additional Manufacturer Narrative · 1
PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2013, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT WAS RECEIVING AUGMENTIN (DATE NOT REPORTED) AS A PREVENTATIVE TREATMENT DUE TO A PERFORMANCE DECREMENT WITH DEVICE USE; HOWEVER, NO INFECTION WAS DIAGNOSED. THE PATIENT REGAINED NORMAL BENEFIT WITH DEVICE USE. NO ADDITIONAL EPISODES WERE REPORTED AS OF THE DATE OF THIS REPORT, (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193886 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |