Brand Name | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN |
Type of Device | 22 CHANNEL COCHLEAR IMPLANT FOR CHILDREN |
Baseline Brand Name | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS |
Baseline Generic Name | 22 CHANNEL COCHLEAR IMPLANT FOR ADULTS |
Baseline Catalogue Number | NA |
Baseline Model Number | C122M |
Other Baseline ID Number | 202203 |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section D) |
COCHLEAR LTD |
14 mars rd |
lane cove |
AUSTRALIA
NSW 2066
|
|
Distributor | COCHLEAR AMERICAS |
400 inverness pkwy., suite 400 |
englewood, CO 80112 |
|
Device Event Key | 141332 |
MDR Report Key | 144964 |
Event Key | 136127 |
Report Number | 1721493-1998-00001 |
Device Sequence Number | 1 |
Product Code | MCM |
Report Source |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/22/1998 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 01/22/1998 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device MODEL Number | C122M |
OTHER Device ID Number | 202518 |
Was Device Available For Evaluation? |
No Answer Provided
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Device Age | 4 yr |
Event Location |
Outpatient Treatment Facility
|
Date Report TO Manufacturer | 01/22/1998 |
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|