Brand Name | NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE |
Type of Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, 2109 |
AS 2109 |
|
Manufacturer Contact |
kristel
kohne
|
1 university avenue |
macquarie university, nsw 2109,
|
AS
2109,
|
|
MDR Report Key | 9248194 |
MDR Text Key | 164116525 |
Report Number | 6000034-2019-02186 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 09321502020268 |
UDI-Public | (01)09321502020268(11)141110(17)161109 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/09/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 11/09/2016 |
Device Model Number | CI422 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/09/2019 |
Initial Date Manufacturer Received |
10/09/2019 |
Initial Date FDA Received | 10/28/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/10/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|