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

Model Number CI-1400-01

Device Problems Expulsion (2933); Material Protrusion/Extrusion (2979); Output Problem (3005)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Type  malfunction  

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 extrusion and inflammation that was treated (type unknown).The recipient is reportedly experiencing decreased performance.A review of the test data indicates potential impedance issues.The recipient will continue to monitored.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient has reportedly resumed device use.No further treatment details will 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 is reportedly experiencing device migration, device extrusion and an infection.The recipient reportedly was treated with ceftriaxone injection, unasyn injection, augmentin suspension.The recipient's infection has resolved.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES 90K¿ 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: 15307532
• MDR Text Key: 300648639
• Report Number: 3006556115-2022-01432
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016816253
• UDI-Public: (01)07630016816253(11)160908(17)180831
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/07/2022; 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2016
• 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 Sex: Male