MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-12-22 for NUCLEUS 24 ABI ABI 24M N/A manufactured by Cochlear Ltd.
[63170903]
This report is submitted on (b)(6), 2016, by (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63170904]
It was reported that the patient's device was explanted (date not reported) due to an unknown issue. Additional information has been requested but not been made available as of the date of this report, (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[66220349]
This report is submitted february 1, 2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2016-02544 |
| MDR Report Key | 6201512 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-12-22 |
| Date of Report | 2017-01-13 |
| Date of Event | 2016-12-08 |
| Date Mfgr Received | 2017-01-13 |
| Device Manufacturer Date | 2014-03-18 |
| Date Added to Maude | 2016-12-22 |
| 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 | 94286555 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS 24 ABI |
| Generic Name | NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Product Code | MHE |
| Date Received | 2016-12-22 |
| Returned To Mfg | 2017-01-06 |
| Model Number | ABI 24M |
| Catalog Number | N/A |
| Lot Number | N/A |
| 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 | 2016-12-22 |