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

Model Number CI-1500-04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 06/21/2023

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

The recipient reportedly experienced an abscess.The recipient was a non-user of the device.The recipient's device was explanted.

Manufacturer Narrative

The explanted device was received by advanced bionics december 13, 2023.Advanced bionics is currently attempting to obtain consent from the recipient.The device remains intact in a locked vault at ab, llc until consent is obtained.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.Due diligence attempts to obtain additional details regarding the recipient's status were unsuccessful.Additional information regarding the recipient's status will not be provided.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 90K¿ ADVANTAGE 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: 17564900
• MDR Text Key: 321346710
• Report Number: 3006556115-2023-01490
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016828638
• UDI-Public: (01)07630016828638(11)160523(17)181130
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Model Number: CI-1500-04
• 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: 05/23/2016
• 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: 46 YR
• Patient Sex: Female