MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-14 for NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT NA manufactured by Cochlear Ltd.
[117033233]
This report is submitted august 14, 2018.
Patient Sequence No: 1, Text Type: N, H10
[117033234]
Per the clinic, the patient experienced pain and a performance decrement with subsequent loss of connection to the internal device; resulting in the decision to explant the device on (b)(6) 2018. The patient was reimplanted with a new device during the same surgery.
Patient Sequence No: 1, Text Type: D, B5
[117625831]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2018-01654 |
| MDR Report Key | 7780582 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2016-05-04 |
| Date Added to Maude | 2018-08-14 |
| 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 | MRS. 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 ABI541 AUDITORY BRAINSTEM IMPLANT |
| Generic Name | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
| Product Code | MHE |
| Date Received | 2018-08-14 |
| Returned To Mfg | 2018-07-31 |
| Model Number | ABI541 |
| Catalog Number | NA |
| Lot Number | NA |
| Device Expiration Date | 2018-05-03 |
| 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 | 2018-08-14 |