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

Model Number CI-1400-01

Device Problems Electrical /Electronic Property Problem (1198); Electro-Static Discharge (2149); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 07/13/2023

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 is reportedly experiencing discomfort with device use and sound quality issues.Programming adjustments were made, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

A review of the device history record was completed and no anomalies were noted.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 the electrode was severed and silicone damage was observed on the top and bottom cover of the device.The device passed photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The failure of this device is attributed to a short from a power node to the case ground at the analog chip.It is believed that electrostatic discharge (esd) led to an overload voltage, damaging structures on case ground node inside the analog integrated circuit.This ultimately caused the device to cease functioning.A corrective action was implemented.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: lacey o'linn ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 17344485
• MDR Text Key: 319374543
• Report Number: 3006556115-2023-01340
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2013
• 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: 11 YR
• Patient Sex: Female