FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1932841
·
Received December 20, 2010
Report
- Report Number
- 6000034-2010-00801
- Event Type
- Injury
- Date Received
- December 20, 2010
- Date of Event
- November 11, 2010
- Report Date
- April 20, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE DEVICE IS NOT AVAILABLE FOR ANALYSIS.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PER PATIENT'S CLINIC, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE ON (B)(6), 2011. THIS REPORT IS FILED (B)(4), 2011.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO AN INFECTION (TYPE NOT REPORTED). THE DEVICE WAS EXPLANTED ON (B)(6), 2010. REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AS OF THE DATE OF THIS REPORT, (B)(6), 1010. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 MO | Required Intervention |