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

Model Number	CI-1400-02H
Medical Device Problem Codes	Intermittent Continuity (1121); Mechanical Problem (1384); Electrical Shorting (2926)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The recipient reportedly experienced sound quality issues and decreased performance.Device testing revealed results within normal limits.Programming adjustments were made; however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another 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 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
Additional information: section d.9.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
Correction section h.6.Advanced bionics considers the investigation into this reportable event as closed.The recipient was reimplanted with another advanced bionics cochlear device.The external visual inspection revealed tool damage to the silicone overmold on the top cover, as well as a severed electrode.This is 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 test performed.The scanning electron microscopy (sem) analysis revealed evidence of damage to the insulation on electrode wires, which could result in a high current leakage between the contacts.It is believed that the parylene wire insulation damage found on electrode wires are the source of the short circuit reported.Sem analysis confirmed the damage to the wire insulation where it passes through the contact which is consistent with the electrodes identified with the short circuit prior to explantation.An internal corrective action was implemented.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
• 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: 19973564
• Report Number: 3006556115-2024-01276
• Device Sequence Number: 17883461
• Product Code: MCM
• UDI-Device Identifier: 07630016816260
• UDI-Public: (01)07630016816260(11)150909(17)170831
• 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: 2016
• Device Explanted Year: 2024
• 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): 08/07/2024

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: 08/31/2017
• Device Model Number: CI-1400-02H
• 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
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/17/2024; 11/11/2024; 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2015
• 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: 14 YR
• Patient Sex: Male