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

Model Number CI-1400-01

Device Problems Mechanical Problem (1384); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing no sound.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event closed.The recipient has experienced a failure in situ.The are no plans for revision at this time.A review of the device history record was completed and no anomalies were noted.No further 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

Advanced bionics considers the investigation into this reportable event closed.The recipient has experienced a failure in situ.The are no plans for revision at this time.A review of the device history record was completed and no anomalies were noted.No further 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.

• 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: 12464987
• MDR Text Key: 272241461
• Report Number: 3006556115-2021-01344
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2011
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2009
• 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: Female