MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE NA manufactured by Cochlear Ltd.
[186278995]
This report is submitted on march 27, 2020.
Patient Sequence No: 1, Text Type: N, H10
[186278996]
Per the clinic, the tip of the electrode array was partially inserted and found to be folded over in the cochlea, resulting in the decision to explant the device. The device was explanted (b)(6) 2020 and the patient was reimplanted with a new device during the same surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00971 |
| MDR Report Key | 9887230 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-12-10 |
| Date Added to Maude | 2020-03-27 |
| 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. KRISTEL KOHNE |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQUARIE 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 CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE |
| Generic Name | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
| Product Code | MCM |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-16 |
| Model Number | CI632 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-27 |