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

Model Number	CI-1400-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Event or Problem Description
The recipient reportedly experienced overly loud sound with device use.Device testing was within normal limits, programming adjustments were made and improvement was noted.The recipient's device was explanted.
Additional Manufacturer Narrative
The recipient was reportedly reimplanted with another advanced bionics cochlear device.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
A review of the device history record was performed at the request of the nca and no anomalies were noted.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 device passed the external visual and the photographic imaging inspections.System lock was verified.The device passed the electrical and mechanical tests performed.The reported complaint of overly loud sound could not be verified during this analysis.This device passed all of 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.
Additional Manufacturer Narrative
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 o'linn ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 16132770
• Report Number: 3006556115-2023-00049
• Device Sequence Number: 3253264
• Product Code: MCM
• UDI-Device Identifier: 07630016816253
• UDI-Public: (01)07630016816253(11)141021(17)160930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/06/2023

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: 09/30/2016
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; Not provided
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/07/2023; 03/29/2023; 05/31/2023; 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2014
• 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: 9 YR
• Patient Sex: Male