Brand Name | NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE |
Type of Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, nsw 2109 |
AS 2109 |
|
MDR Report Key | 9584617 |
MDR Text Key | 174857785 |
Report Number | 6000034-2020-00068 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 09321502007320 |
UDI-Public | (01)09321502007320(11)100728(17)120727 |
Combination Product (y/n) | N |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
10/23/2020 |
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 | 07/27/2012 |
Device Model Number | CI24RE (CA) |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/01/2020 |
Initial Date Manufacturer Received |
12/26/2019
|
Initial Date FDA Received | 01/13/2020 |
Supplement Dates Manufacturer Received | 01/16/2020 09/07/2020 10/23/2020
|
Supplement Dates FDA Received | 02/10/2020 09/27/2020 10/26/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|