FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2101165
·
Received May 24, 2011
Report
- Report Number
- 6000034-2011-00363
- Event Type
- Injury
- Date Received
- May 24, 2011
- Date of Event
- February 26, 2004
- Report Date
- February 6, 2012
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR ANALYSIS.THIS REPORT IS FILED (B)(4), 2012.DEVICE NOT AVAILABLE FOR ANALYSIS.
Additional Manufacturer Narrative · 1
(B)(4). DEVICE IS NOT AVAILABLE FOR ANALYSIS.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO INFECTION. THE DEVICE WAS EXPLANTED (B)(6), 2004, AND THE PATIENT WAS IMPLANTED IN THE CONTRALATERAL EAR WITH A NEW DEVICE DURING THE SAME SURGERY. NO OTHER DETAILS HAVE BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(6), 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI24R (CS) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |