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

Model Number MI1200 SYNCHRONY PIN

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 08/01/2020

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 noticed the device has not been working as well in the last few months compared to before.

Event Description

The user noticed the device has not been working as well in the last few months compared to before.The user will be re-implanted but no date has been set yet.

Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.In addition information on the implant registration card states that two channels were left outside of cochlea at implantation surgery.Further two additional channels were disabled due to a postoperative migration out of cochlea.However to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is planned but no date has been scheduled yet.

Event Description

The user noticed the device has not been working as well in the last few months compared to before.The user was re-implanted with a shorter electrode variant.

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.In addition information on the implant registration card states that two channels were left outside of cochlea at implantation surgery.Further two additional channels were disabled due to a postoperative migration out of cochlea.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: 10626326
• MDR Text Key: 209772886
• Report Number: 9710014-2020-00569
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094058
• UDI-Public: (01)09008737094058
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR