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

Model Number	CI-1400-02H
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The recipient reportedly experienced decreased performance.Device testing revealed open electrodes.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
Additional Manufacturer Narrative
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 per 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 external visual inspection revealed the electrode was severed, as well as silicone damage on the top and bottom cover.These are believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.The reported complaint of open electrodes could not be verified during analysis, which was limited in some respects due to the electrode being damaged prior to receipt.This device passed all of the tests performed.This older device configuration in not currently manufactured.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: jennifer rhudy ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 17058886
• Report Number: 3006556115-2023-01024
• Device Sequence Number: 5044953
• Product Code: MCM
• UDI-Device Identifier: 07630016816260
• UDI-Public: (01)07630016816260(11)150625(17)170630
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2017
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/28/2023; 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2015
• 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
• Patient Age: 9 YR
• Patient Sex: Male