MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-02 for NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM ABI24M manufactured by Cochlear Ltd ..
[17205122]
Per the clinic, the patient sustained a head trauma (date not reported) resulting in loss of connection to the internal device. The implanted device remains.
Patient Sequence No: 1, Text Type: D, B5
[17483744]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[43020344]
Per the clinic, the device was explanted (b)(6) 2015, and the patient was reimplanted with another manufacturer's device during the same surgery. This report is filed april 7, 2016.
Patient Sequence No: 1, Text Type: N, H10
[47905276]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2015-01238 |
| MDR Report Key | 4889605 |
| Report Source | 07 |
| Date Received | 2015-07-02 |
| Date of Report | 2016-03-21 |
| Date Mfgr Received | 2015-02-20 |
| 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 | 2015-12-15 |
| 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 |