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

Model Number	ABI541
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 8886221
• Report Number: 6000034-2019-01049
• Device Sequence Number: 11362063
• Product Code: MHE
• UDI-Device Identifier: 09321502020404
• UDI-Public: (01)09321502020404(11)110520(17)130519
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P000015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020
• Report Date (Section F): 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Distributor Facility Aware Date: 07/18/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 08/13/2019