Brand Name | NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE |
Type of Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR BONE ANCHORED SOLUTIONS AB |
konstruktionsvigen 14 |
molnlycke, 435 3 3 |
AS 435 33 |
|
Manufacturer (Section G) |
COCHLEAR BONE ANCHORED SOLUTIONS AB |
konstruktionsvigen 14 |
|
molnlycke, 435 3 3 |
SW
435 33
|
|
Manufacturer Contact |
roberta
loveday
|
1 university avenue |
macquarie university, nsw 2109
|
AS
2109
|
|
MDR Report Key | 17467629 |
MDR Text Key | 320472011 |
Report Number | 6000034-2023-02447 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 09321502036580 |
UDI-Public | (01)09321502036580(11)210416(17)230415 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
07/12/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/07/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 04/15/2023 |
Device Model Number | CI632 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/10/2023 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/12/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/16/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Male |