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

Model Number CI-1600-05

Device Problems Mechanical Problem (1384); Expulsion (2933); Material Protrusion/Extrusion (2979)

Patient Problems Abscess (1690); Bacterial Infection (1735); Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

Event Description

The recipient reportedly experienced an infection and device extrusion.The recipient presented with an infection with retroauricular abscess in (b)(6) 2020, and began antibiotic management.A surgical cleaning was performed on (b)(6) 2021, with good evolution, until a bacteria culture on (b)(6) 2021 showed the presence of pseudomona, staphylococcus.The recipient started the antibiotics amoxy clavulanic and cefuroxime for 15 days.In (b)(6) 2021, the recipient presented with device extrusion.The device was explanted.The recipient was not reimplanted.The recipient is reportedly hospitalized due to antibiotic resistance.

Manufacturer Narrative

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

Manufacturer Narrative

The recipient's infection has reportedly resolved.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.Additional treatment details will not be provided.The external visual inspection revealed cuts in the silicone overmold on the top and bottom covers, and near the fantail region, as well as a severed electrode.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the some of the electrical tests performed.The device passed the mechanical test performed.This device was explanted for medical reasons.However, this device had an electrode short in the electrode pocket.A corrective action was implemented.This version of the hires ultra 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¿ ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: alexandra gonzalez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 12485261
• MDR Text Key: 271852324
• Report Number: 3006556115-2021-01324
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016855696
• UDI-Public: (01)07630016855696(11)190918(17)220831
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/18/2021

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: 08/31/2022
• Device Model Number: CI-1600-05
• 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: 09/16/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/05/2022; 03/31/2022; 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• 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): Hospitalization; Required Intervention
• Patient Sex: Male