MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-07-02 for NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM ABI24M manufactured by Cochlear Ltd ..
[16495105]
Per the clinic, the patient experienced a loss of connection to the internal device. Reprogramming attempts were made; however, the issue could not be resolved. The implanted device remains.
Patient Sequence No: 1, Text Type: D, B5
[16608532]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[41729164]
Per the clinic, the device was explanted (b(6) 2015, and the patient was reimplanted with a new device during the same surgery. This report is filed april 1, 2016.
Patient Sequence No: 1, Text Type: N, H10
[48005746]
Correction; the common device name and product name is mhe; and not mcm as previously reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2015-01403 |
| MDR Report Key | 4889476 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-07-02 |
| Date of Report | 2016-03-09 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2015-07-01 |
| Date Added to Maude | 2015-07-06 |
| 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 | AUDIOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ANGEL WRIGHT |
| Manufacturer Street | 13059 EAST PEAKVIEW AVENUE |
| Manufacturer City | CENTENNIAL CO 80111 |
| Manufacturer Country | US |
| Manufacturer Postal | 80111 |
| Manufacturer Phone | 3037909010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Generic Name | MHE |
| Product Code | MHE |
| Date Received | 2015-07-02 |
| Returned To Mfg | 2015-11-25 |
| Model Number | ABI24M |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR LTD . |
| Manufacturer Address | 14 MARS RD PO BOX 629 LANE COVE, NSW 2066 AS 2066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-02 |