Brand Name | HIRES¿ ULTRA IMPLANT |
Type of Device | COCHLEAR IMPLANT |
Manufacturer (Section D) |
ADVANCED BIONICS, LLC |
28515 westinghouse place |
valencia CA 91355 |
|
Manufacturer Contact |
delilah
garcia
|
28515 westinghouse place |
valencia, CA 91355
|
|
MDR Report Key | 8410368 |
MDR Text Key | 138495526 |
Report Number | 3006556115-2019-00090 |
Device Sequence Number | 0 |
Product Code |
MCM
|
PMA/PMN Number | P960058 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
02/15/2019 |
2 Devices were Involved in the Event: |
1
2
|
2 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 | 12/31/2019 |
Device Model Number | CI-1600-04 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/03/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/11/2019 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 04/05/2019 05/08/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/03/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 0 |
Patient Outcome(s) |
Required Intervention;
|
|
|