MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-29 for NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NA manufactured by Cochlear Ltd.
[186549421]
This report is submitted on march 30, 2020.
Patient Sequence No: 1, Text Type: N, H10
[186549422]
Per the clinic, the patient experienced an infection (unknown if the infection was device related) which was unsuccessfully treated with iv antibiotics resulting in the device being explanted on (b)(6) 2020. It is unknown if there are plans to re-implant the patient with another device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00856 |
| MDR Report Key | 9896208 |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Report Date | 2020-03-30 |
| Date Reported to FDA | 2020-03-30 |
| Date Reported to Mfgr | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-11-19 |
| Date Added to Maude | 2020-03-29 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE |
| Generic Name | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
| Product Code | MCM |
| Date Received | 2020-03-29 |
| Returned To Mfg | 2020-03-19 |
| Model Number | CI622 |
| 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, 2109 AS 2109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-29 |