MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA 3D IMPLANT; COCHLEAR IMPLANT

Model Number CI-1601-04

Device Problems Mechanical Problem (1384); Impedance Problem (2950)

Patient Problems Fall (1848); Head Injury (1879); Hearing Impairment (1881)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Following a head trauma event the recipient experienced loss of sound perception.External equipment was exchanged, however the issue did not resolve.Lock was achieved during device testing however, impedance measurements suggested open electrodes across the array.Further testing will be conducted to evaluate device position.Advanced bionics is still in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

Imaging revealed proper device placement.Revision surgery will be scheduled.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 the electrode was severed and silicone damage was observed on the top cover of the device.This is believed to have occurred during revision surgery.Photographic imaging inspection revealed broken electrode wires within the fantail.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.The scanning electron microscopy (sem) analysis revealed tensile breaks within the fantail.The device passed the residual gas analysis (rga) test.Sem analysis revealed broken electrode wires near the fantail, induced by the trauma reported.It is believed that these breaks caused the open impedances measured at the clinic.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient's device was explanted.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

Advanced bionics considers the investigation into this reportable event as closed.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¿ ULTRA 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: heidi white ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 16163627
• MDR Text Key: 307459332
• Report Number: 3006556115-2023-00080
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016878039
• UDI-Public: (01)07630016878039(11)200113(17)230131
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/23/2023; 04/24/2023; 08/17/2023; 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2020
• 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: 5 YR
• Patient Sex: Female