Brand Name | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM |
Type of Device | MHE |
Manufacturer (Section D) |
COCHLEAR LTD. |
1 university avenue |
macquarie university, nsw 2109 |
AS 2109 |
|
Manufacturer Contact |
bianca
hanlon
|
1 university avenue |
macqaurie university, nsw 2109
|
AS
2109
|
2 9428 655
|
|
MDR Report Key | 6136955 |
MDR Text Key | 61186480 |
Report Number | 6000034-2016-02398 |
Device Sequence Number | 1 |
Product Code |
MHE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P000015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/02/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/30/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | CI8+1M |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/23/2016 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/02/2016 |
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;
|
Patient Age | 37 YR |
|
|