Brand Name | HIRES 90K¿ ADVANTAGE IMPLANT |
Type of Device | COCHLEAR IMPLANT |
Manufacturer (Section D) |
ADVANCED BIONICS, LLC |
28515 westinghouse place |
valencia CA 91355 |
|
MDR Report Key | 9088181 |
MDR Text Key | 164901334 |
Report Number | 3006556115-2019-00551 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 07630016832185 |
UDI-Public | (01)07630016832185(11)180515(17)201231 |
Combination Product (y/n) | N |
PMA/PMN Number | P960058 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
08/28/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 12/31/2020 |
Device Model Number | CI-1500-04 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 09/19/2019 |
Supplement Dates Manufacturer Received | Not provided Not provided Not provided
|
Supplement Dates FDA Received | 09/25/2019 11/12/2019 03/24/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 4 YR |