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

Model Number CI-1500-04

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Audible Prompt/Feedback Problem (4020)

Patient Problems Unspecified Infection (1930); Pain (1994); Tinnitus (2103); Dizziness (2194); Discomfort (2330)

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

The recipient is reportedly experiencing sound quality issues due to middle ear infections and dizziness.The recipient is also experiencing tinnitus.In (b)(6) 2020, the recipient experienced the first middle ear infection and was hospitalized and treated with antibiotics.After being discharged the recipient continued to experience dizziness accompanied by tinnitus.In (b)(6) 2020, the middle ear infection recurred and the recipient could no longer hear with the device.According to the recipient¿s physician, the infection may have formed biofilm and is contributing to the recipient¿s sound quality issues.Revision surgery is being considered.

Manufacturer Narrative

The recipient was reportedly hospitalized in (b)(6) 2020, for the treatment of the infection.The recipient is doing well.The recipient is not experiencing pain or discomfort with device use.Revision surgery is still being considered.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 recipient's device will reportedly not be explanted at this time.The recipient's issues resolved.The recipient continues to use the device.Additional treatment details will not be provided.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 not reimplanted.The recipient reportedly recovered and the infection resolved.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 tool damage on the top and bottom covers, a cut on the electrode near the fantail, and an extruded contact pas on an electrode.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed electrode wire near the fantail.This is believed to have occurred during revision surgery.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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¿ ADVANTAGE 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: 10969865
• MDR Text Key: 220399013
• Report Number: 3006556115-2020-01536
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016832185
• UDI-Public: (01)07630016832185(11)170915(17)200731
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 11/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• 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 Sex: Female