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

Model Number CI-1601-04

Device Problems Fracture (1260); Insufficient Information (3190)

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

Event Date 02/14/2022

Event Type  malfunction  

Event Description

The company was informed that the recipient's device was reportedly explanted.Advanced bionics is in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

The initial report is corrected to march 2, 2022.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

The recipient reportedly experienced electrode migration.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient reportedly needed a better bone bed.During this procedure the electrode migrated.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.The recipient is reportedly doing well.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 has not provided consent despite several requests to the recipient¿s medical institution to obtain and provide the consent.As a result, no conclusion can be drawn at this time.If the consent is received at a later date, the issue will be re-opened and the results of the analysis will be reported.The device remains intact in a locked vault at ab, llc until consent is obtained.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: jennifer rhudy ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 13736832
• MDR Text Key: 290195534
• Report Number: 3006556115-2022-00394
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016878039
• UDI-Public: (01)07630016878039(11)200626(17)230630
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2020
• 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 Age: 77 YR
• Patient Sex: Female