MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for Nucleus CI532 NA manufactured by Cochlear Ltd.
[186665852]
Per the clinic, the device was explanted (date not reported) due to poor performance with device use. It is unknown whether the patient was implanted with another device, as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00925 |
| MDR Report Key | 9908242 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-09 |
| Date Facility Aware | 2020-03-09 |
| Report Date | 2020-04-01 |
| Date Reported to FDA | 2020-04-01 |
| Date Reported to Mfgr | 2020-04-01 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | Nucleus |
| Generic Name | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
| Product Code | MCM |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-09 |
| Model Number | CI532 |
| Catalog Number | NA |
| Lot Number | NA |
| Device Expiration Date | 2018-08-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-31 |