MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ IMPLANT; COCHLEAR IMPLANT

Model Number	CI-1400-01
Medical Device Problem Codes	Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Skin Infection (4544); Swelling/ Edema (4577)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The recipient reportedly experienced trauma at the implant site.On (b)(6) 2019, the recipient presented with edema and was treated with amoxicillin and sulbactam.The edema resolved.On (b)(6) 2020, the edema recurred.The recipient was treated with cetibuten, however, the issue did not resolve.On (b)(6) 2020, the recipient presented with an extruded device.The recipient underwent skin flap revision surgery.On (b)(6) 2021, the recipient presented with an extruded device again, and the recipient underwent explant surgery.The recipient was not reimplanted.The recipient recovered well.
Additional Manufacturer Narrative
The recipient's extruded device was reportedly a result of a biofilm infection.The recipient has healed well following explant surgery and the infection resolved.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed extruded contact pads at some electrodes.In addition, there was a missing contact pad at an electrode.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This version of the hires 90k device is no longer distributed.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES 90K¿ IMPLANT
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: lacey mcdonald ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 12022519
• Report Number: 3006556115-2021-00813
• Device Sequence Number: 11986530
• Product Code: MCM
• UDI-Device Identifier: 07630016816253
• UDI-Public: (01)07630016816253(11)151016(17)170930
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/25/2021

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: 09/30/2017
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/24/2021; 09/28/2021; 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male