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

Model Number MI1000 MED-EL CONCERT

Device Problems Output Problem (3005); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 11/30/2021

Event Type  Injury  

Event Description

The user has been reimplanted with a new device on (b)(6) 2021.As per explant report form the explantation was due to loss of function.

Manufacturer Narrative

The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Event Description

The recipient has been reimplanted with a new device on (b)(6)2021.As per explant report form the explantation was due to loss of function.

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 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.

• 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: 13075426
• MDR Text Key: 282700960
• Report Number: 9710014-2021-01060
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737062767
• UDI-Public: (01)09008737062767
• 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
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2013
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• 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: 61 YR
• Patient Sex: Female