MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-30 for NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM CI8+1M manufactured by Cochlear Ltd..
[61186480]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[61186481]
Per the clinic, the device was electively explanted on (b)(6) 2016 due to non-use. There are no plans to re-implant the patient with a new device.
Patient Sequence No: 1, Text Type: D, B5
[64741568]
This report is submitted january 13, 2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2016-02398 |
| MDR Report Key | 6136955 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-30 |
| Date of Report | 2016-12-02 |
| Date of Event | 2016-10-26 |
| Date Mfgr Received | 2016-12-02 |
| Date Added to Maude | 2016-11-30 |
| 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. BIANCA HANLON |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQAURIE UNIVERSITY, NSW 2109 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2109 |
| Manufacturer Phone | 2 9428 655 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Generic Name | MHE |
| Product Code | MHE |
| Date Received | 2016-11-30 |
| Returned To Mfg | 2016-11-23 |
| Model Number | CI8+1M |
| 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 | 2016-11-30 |