MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-06 for NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM ABI541 manufactured by Cochlear Ltd..
[48916601]
This report is filed july 7, 2016. Implanted device remains.
Patient Sequence No: 1, Text Type: N, H10
[48916602]
Per the clinic, the patient was hospitalized (date not reported) due to experiencing post-operative headaches and intracranial pressure. Additional information has been requested; however, has not yet been made available as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2016-01332 |
| MDR Report Key | 5774273 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-07-06 |
| Date of Report | 2016-06-22 |
| Date Mfgr Received | 2016-06-22 |
| Date Added to Maude | 2016-07-06 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | MACQUARIE 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 | 2016-07-06 |
| Model Number | ABI541 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR LTD. |
| Manufacturer Address | 1 UNIVERSITY AVENUE MACQAURIE UNIVERSITY, NSW 2109 AS 2109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-07-06 |