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

Model Number MI1210 SYNCHRONY ST

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 03/25/2021

Event Type  malfunction  

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

Hearing performance with the device is affected.

Event Description

Hearing performance with the device is affected.Re-implantation is considered but not yet scheduled.

Manufacturer Narrative

Additional information: according to currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.However, a device investigation is necessary to determine a root cause.Re-implantation is considered but no date has been scheduled yet.

Manufacturer Narrative

Additional information: according to currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.However, a device investigation is necessary to determine a root cause.The concerned device was explanted but has not been received for investigation yet.

Event Description

Hearing performance with the device was affected.Re-implantation has been performed.Despite requested, the concerned device has not been received for investigation yet.

Manufacturer Narrative

Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.The problems given in the recipient report appear to match the damage found.Other damages found during device investigation are most likely related to the explantation surgery.This is a final report.

Event Description

Hearing performance with the device was affected.Re-implantation has been performed.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 11699893
• MDR Text Key: 246465710
• Report Number: 9710014-2021-00286
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737331825
• UDI-Public: (01)09008737331825
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/09/2019
• Device Model Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 33333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Sex: Male