MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-21 for NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT N/A manufactured by Cochlear Ltd.
[70514421]
This report is submitted on (b)(6) 2017.
Patient Sequence No: 1, Text Type: N, H10
[70514422]
Per the clinic, the patient experienced an infection resulting in the decision to explant the device. The receiver stimulator was explanted on (b)(6) 2017, however the electrode array was left in situ. There are no plans to re-implant the patient with a new device.
Patient Sequence No: 1, Text Type: D, B5
[74509038]
Per the clinic, the infection was treated with iv antibiotics (date and duration not reported). This report is submitted on may 05, 2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2017-00574 |
| MDR Report Key | 6423143 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-21 |
| Date of Report | 2017-04-11 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-04-11 |
| Device Manufacturer Date | 2015-09-18 |
| Date Added to Maude | 2017-03-21 |
| 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 |
| Reporter Occupation | AUDIOLOGIST |
| 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 |
| Manufacturer Phone | 94286555 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT |
| Generic Name | NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Product Code | MHE |
| Date Received | 2017-03-21 |
| Returned To Mfg | 2017-03-07 |
| Model Number | ABI541 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Device Expiration Date | 2017-09-18 |
| 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 | 2017-03-21 |