Brand Name | HIRES 90K¿ IMPLANT |
Type of Device | COCHLEAR IMPLANT |
Manufacturer (Section D) |
ADVANCED BIONICS, LLC |
28515 westinghouse place |
valencia CA 91355 |
|
MDR Report Key | 9447582 |
MDR Text Key | 170212969 |
Report Number | 3006556115-2019-00738 |
Device Sequence Number | 1 |
Product Code |
MCM
|
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 |
Report Date |
11/14/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/10/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 10/31/2014 |
Device Model Number | CI-1400-01 |
Was Device Available for Evaluation? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 8 YR |
|
|