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

Model Number AB-5100R

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

Patient Problems Acoustic Shock (1693); Headache (1880)

Event Date 08/10/2023

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 reportedly experienced sound quality issues followed by a shocking sensation and headaches with device use.External equipment was exchanged; however, the issue was not resolved.The recipient's device was explanted.The recipient was reimplanted with another cochlear device.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient was reimplanted with another advanced bionics cochlear device.The external visual inspection revealed damaged to the braze, and the epoxy header.In addition, the electrode was severed.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical tests performed.The device passed the mechanical tests performed.The reported complaint of overly loud sound could not be verified during this analysis, which was limited in some respects due to the electrode being damaged prior to receipt.This device passed all of the tests performed.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: CLARION¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: laurel masamitsu ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 17848312
• MDR Text Key: 324673067
• Report Number: 3006556115-2023-01729
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2000
• Device Model Number: AB-5100R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/1998
• 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: 27 YR
• Patient Sex: Male