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

Model Number MI1200 SYNCHRONY

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 10/13/2020

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

The user can no longer hear with their right side device.

Event Description

The user can no longer hear with their right side device.The user reported a sudden loss of hearing with the device.Prior to this the user was doing well with her implant.The recipient was re-implanted.

Manufacturer Narrative

Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.Further in situ measurements show two channels involved in a short circuit since implantation due to undetermined reasons.The problems given in the recipient report appear to match the damage found.This is a final report.

• 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: 10688465
• MDR Text Key: 211645062
• Report Number: 9710014-2020-00603
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• 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: 01/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR