MAUDE Adverse Event Report: COCHLEAR LTD. NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM; MHE

Model Number ABI24M

Device Problem No Device Output (1435)

Patient Problem Hearing Impairment (1881)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

Implanted device remains.

Event Description

Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device, however, the issue could not be resolved.The implanted device remains.Re-implantation is planned but has not occurred as of the date of this report, october 07, 2016.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2016, and the patient was reimplanted with a another cochlear device.This report is filed november 22, 2016.Device not yet received by manufacturer.

Manufacturer Narrative

This report is submitted on march 27, 2017.

• Brand Name: NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
• Type of Device: MHE
• Manufacturer (Section D): COCHLEAR LTD.; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 6010140
• MDR Text Key: 56799935
• Report Number: 6000034-2016-02060
• Device Sequence Number: 1
• Product Code: MHE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P000015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ABI24M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR