MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number MI1200 SYNCHRONY

Device Problem Migration (4003)

Patient Problem Implant Pain (4561)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

There has been a partial migration of the electrode array out of the cochlea.A ct scan revealed 4 channels to be extra-cochlear.The user also has a pressure like pain that surrounds her implant and travels down the right side of her neck.The pain began before the concerned implant was activated.The pain improves when the audio processor is removed but it does not totally resolve it.The right side of the face becomes red and swollen sometimes, with or without use of the device.The cause of the swelling is unknown.In addition, the user frequently experiences headaches/migraines following mapping changes.The user is scheduled to be re-implanted.

Manufacturer Narrative

Conclusion: device investigation did not reveal any damage or malfunction.According to the received information from the field, a partial migration of the active electrode out of cochlea was observed.Furthermore, pain at the implant site, which is a known post-operative side-effect of ci implantation, was present since implantation regardless of the use of the audioprocessor.This is a final report.

Event Description

There has been a partial migration of the electrode array out of the cochlea.The user also has a pressure like pain that surrounds her implant and travels down the right side of her neck.The pain began before the concerned implant was activated.The pain improves when the audio processor is removed but it does not totally resolve it.The right side of the face becomes red and swollen sometimes, with or without use of the device.The cause of the swelling is unknown.In addition, the user frequently experiences headaches/migraines following mapping changes.The user was re-implanted.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 10540425
• MDR Text Key: 207145669
• Report Number: 9710014-2020-00518
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094041
• UDI-Public: (01)09008737094041
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR