MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-09-07 for NUCLEUS HYBRID L24 CI24RE (L24) N/A manufactured by Cochlear Ltd.
[119486965]
This report is submitted on september 7, 2018, by cochlear limited on behalf of cochlear americas. Exemption number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119486966]
Per the clinic, the patient developed an infection resulting in the decision to explant the device. The implanted device remains at this time. However, explant is planned but has not taken place at the time of this report. Additional information has been requested but has not been made available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
[130668337]
Per the clinic, the device was explanted on (b)(6) 2018. This report is filed on october 05, 2018. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2018-01863 |
| MDR Report Key | 7854187 |
| Report Source | USER FACILITY |
| Date Received | 2018-09-07 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-08-30 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2018-01-09 |
| Date Added to Maude | 2018-09-07 |
| 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 HYBRID L24 |
| Generic Name | NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM |
| Product Code | PGQ |
| Date Received | 2018-09-07 |
| Returned To Mfg | 2018-09-27 |
| Model Number | CI24RE (L24) |
| Catalog Number | N/A |
| Lot Number | N/A |
| 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 | 2018-09-07 |