MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-13 for NUCLEUS HYBRID L24 CI24RE (L24) N/A manufactured by Cochlear Ltd.
[91877026]
This report is submitted on november 14, 2017, by cochlear limited on behalf of cochlear americas. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91877027]
Per the clinic, the patient experienced poor performance with device use and a subsequent reduction in clinical benefit, resulting in the decision to explant. The device was explanted on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
[107370616]
Patient Sequence No: 1, Text Type: N, H10
Report Number | 6000034-2017-02081 |
MDR Report Key | 7026950 |
Report Source | USER FACILITY |
Date Received | 2017-11-13 |
Date of Report | 2017-12-19 |
Date of Event | 2017-10-25 |
Date Mfgr Received | 2017-12-19 |
Device Manufacturer Date | 2016-03-11 |
Date Added to Maude | 2017-11-13 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. SUJEEWA WIJESINGHE |
Manufacturer Street | 1 UNIVERSITY AVENUE |
Manufacturer City | MACQAURIE UNIVERSITY, NSW 2109 |
Manufacturer Country | AS |
Manufacturer Postal | 2109 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | NUCLEUS HYBRID L24 |
Generic Name | NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM |
Product Code | PGQ |
Date Received | 2017-11-13 |
Returned To Mfg | 2017-12-05 |
Model Number | CI24RE (L24) |
Catalog Number | N/A |
Lot Number | N/A |
Device Expiration Date | 2018-03-10 |
Operator | LAY USER/PATIENT |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | COCHLEAR LTD |
Manufacturer Address | 1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, NSW 2109 AS 2109 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2017-11-13 |