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

Model Number CI-1400-02H

Device Problems Mechanical Problem (1384); Output below Specifications (3004)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/10/2022

Event Type  Injury  

Event Description

The recipient reportedly experienced open electrodes.The recipient presented with decreased performance.A ct scan was performed and revealed no abnormalities.The recipient's device was explanted.

Manufacturer Narrative

The recipient was 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.

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed extruded contact pads.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The condition of the electrode prevented an electrical test from being performed.The scanning electron microscopy analysis revealed that electrode wires were broken at the electrode contact, an electrode wire was broken near the ground ring.All broken wires exhibit evidence of mechanical damage.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The scanning microscopy analysis revealed broken electrode wires in the array.It is believed that these breaks caused to open impedances measured at the clinic.Advanced bionics will continue to monitor failure modes of this type.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
• Type of Device: 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: 13829881
• MDR Text Key: 287522305
• Report Number: 3006556115-2022-00335
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016816260
• UDI-Public: (01)07630016816260(11)150604(17)170531
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2017
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/10/2022; 08/08/2022; 02/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Sex: Male