MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT; NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM

Model Number ABI541

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Deafness (1801)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 13, 2017, by cochlear limited on behalf of cochlear americas.(b)(4).

Event Description

Per the clinic, the patient experienced no auditory response with the device.Subsequently, a ct scan performed on (b)(6) 2017, revealed that the implant had migrated out of the cochlea.Revision surgery to reposition the device is planned; however, yet to occur as of the date of this report november 13, 2017.

• Brand Name: NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT
• Type of Device: NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 7023816
• MDR Text Key: 91875793
• Report Number: 6000034-2017-02060
• Device Sequence Number: 1
• Product Code: MHE
• UDI-Device Identifier: 09321502020404
• UDI-Public: (01)09321502020404(11)160129(17)180128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2018
• Device Model Number: ABI541
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2016
• 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