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

Model Number ABI541

Device Problem No Device Output (1435)

Patient Problem Deafness (1801)

Event Date 08/25/2015

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.It is unknown if there are plans to explant the device and reimplant the patient with a new device as of the date of this report.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2016, and the patient was reimplanted with a new device on the contralateral side during the same surgery.Device not returned to manufacturer.

Manufacturer Narrative

Correction: the device was not explanted as previously reported.The device remains insitu.This report is filed june 21, 2016.Implanted device remains.

• Brand Name: NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
• Type of Device: MHE
• Manufacturer (Section D): COCHLEAR LTD.; 1 university avenue; po box 629; macqaurie university, nsw 2109 ; AS 2109
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 5069689
• MDR Text Key: 25498669
• Report Number: 6000034-2015-01898
• Device Sequence Number: 1
• Product Code: MHE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P000015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Audiologist
• Type of Report: Followup,Followup
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ABI541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 68 YR