Brand Name | NUCLEUS 24 |
Type of Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, nsw 2109 |
AS 2109 |
|
Manufacturer Contact |
sujeewa
wijesinghe
|
1 university avenue |
macqaurie university, nsw 2109
|
AS
2109
|
|
MDR Report Key | 7005437 |
MDR Text Key | 91182293 |
Report Number | 6000034-2017-02054 |
Device Sequence Number | 1 |
Product Code |
MCM
|
Combination Product (y/n) | N |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Type of Report
| Initial,Followup |
Report Date |
11/24/2017 |
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 Model Number | CI24M |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/09/2017 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/30/2017 |
Initial Date FDA Received | 11/06/2017 |
Supplement Dates Manufacturer Received | 11/24/2017
|
Supplement Dates FDA Received | 12/03/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
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;
|
|
|