MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-04 for NUCLEUS HYBRID L24 CI24RE (L24) NA manufactured by Cochlear Bone Anchored Solutions Ab.
[96442696]
This report is submitted on january 5, 2018, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[96442697]
Per the clinic, the patient experienced a performance decrement and pain with device use. Subsequently, the device was explanted on (b)(6) 2017, and the patient was reimplanted with another cochlear device during the same surgery.
Patient Sequence No: 1, Text Type: D, B5
[107874270]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2018-00019 |
| MDR Report Key | 7165998 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-04 |
| Date of Report | 2018-01-30 |
| Date of Event | 2017-11-21 |
| Date Mfgr Received | 2018-01-30 |
| Device Manufacturer Date | 2015-10-12 |
| Date Added to Maude | 2018-01-04 |
| 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 BIANCA PRIES |
| 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 | 2018-01-04 |
| Returned To Mfg | 2017-12-20 |
| Model Number | CI24RE (L24) |
| Catalog Number | NA |
| Lot Number | NA |
| Device Expiration Date | 2017-10-11 |
| 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 BONE ANCHORED SOLUTIONS AB |
| Manufacturer Address | KONSTRUKTIONSV?GEN 14 PO BOX 82 M?LNLYCKE, 435 22 SW 435 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-04 |