MAUDE Adverse Event Report: ADVANCED BIONICS, LLC CLARION IMPLANT; COCHLEAR IMPLANT

Model Number AB-5100H

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

Patient Problems Pain (1994); Twitching (2172); Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient¿s device is considered to be a failure in-situ.A review of the device history record was completed and no anomalies were noted.Additional details will not be provided.This is the final report.

Event Description

Advanced bionics was informed that lock was unable to be maintained for the recipient¿s device during device testing.The recipient has reportedly been a non-user since 2018 because of pain, and an eye twitch, with and without device use.Testing of the device could not be completed due to no lock and discomfort reported by the recipient.Programming adjustments were not attempted as the recipient lost their external equipment.The recipient prefers to remain a non-user at this time.Additional details were not provided.

• Brand Name: CLARION IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: alexandra gonzalez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 10248545
• MDR Text Key: 198688745
• Report Number: 3006556115-2020-00516
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 06/08/2020

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: 12/01/2002
• Device Model Number: AB-5100H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2001
• 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