Brand Name | NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM |
Type of Device | PGQ |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, nsw 2109 |
AS 2109 |
|
Manufacturer (Section G) |
COCHLEAR AMERICAS |
13059 east peakview avenue |
centennial, co 80111, us |
centennial CO 80111 |
|
Manufacturer Contact |
pavana
nayak
|
1 university avenue |
macquarie university, nsw 2109
|
AS
2109
|
2 9428 655
|
|
MDR Report Key | 6062747 |
MDR Text Key | 58598893 |
Report Number | 6000034-2016-02133 |
Device Sequence Number | 1 |
Product Code |
PGQ
|
Combination Product (y/n) | N |
PMA/PMN Number | P130016 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Type of Report
| Initial,Followup |
Report Date |
11/17/2016 |
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 | 05/27/2017 |
Device Model Number | CI24RE (L24) |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/28/2016 |
Distributor Facility Aware Date | 11/17/2016 |
Device Age | 1 YR |
Initial Date Manufacturer Received |
10/17/2016
|
Initial Date FDA Received | 10/27/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 11/27/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/27/2015 |
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 | 70 YR |
|
|