Brand Name | NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT |
Type of Device | NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, 2109 |
AS 2109 |
|
Manufacturer Contact |
kristel
kohne
|
1 university avenue |
macquarie university, nsw 2109,
|
AS
2109,
|
|
MDR Report Key | 9263971 |
MDR Text Key | 164615847 |
Report Number | 6000034-2019-02211 |
Device Sequence Number | 1 |
Product Code |
MHE
|
UDI-Device Identifier | 09321502020404 |
UDI-Public | (01)09321502020404(11)180414(17)200413 |
Combination Product (y/n) | N |
Reporter Country Code | SW |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/11/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/31/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 04/13/2020 |
Device Model Number | ABI541 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 10/11/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/14/2018 |
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;
|