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

Model Number ABI541

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

The device was explanted due to a suspected device failure.Analysis found a hermetic seal failure.The conclusion from device analysis is that the loss of function was caused by moisture penetrating the hermetic seal and impacting the device function.This report is submitted on august 13, 2019.

Event Description

Per the clinic, the patient was explanted on (b)(6) 2019 because of a suspected device failure.The patient was re-implanted with a device at the same surgery.

Manufacturer Narrative

Correction: the correct date of awareness (b4) and (g4) should be 06 june 2019, not 18 july 2019 as previously reported.This report is submitted on 6 march 2020.

• 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, 2109 ; AS 2109
• MDR Report Key: 8886221
• MDR Text Key: 154106991
• Report Number: 6000034-2019-01049
• Device Sequence Number: 1
• Product Code: MHE
• UDI-Device Identifier: 09321502020404
• UDI-Public: (01)09321502020404(11)110520(17)130519
• Combination Product (y/n): N
• PMA/PMN Number: P000015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/13/2019,03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2013
• Device Model Number: ABI541
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/13/2019
• Distributor Facility Aware Date: 07/18/2019
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention