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

Model Number MI1000 MED-EL CONCERT

Device Problems Device Appears to Trigger Rejection (1524); Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Skin Tears (2516)

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 electrode lead can be seen in the external auditory canal.

Manufacturer Narrative

Additional information: according to the received information, the active electrode lead extruded into the external ear canal affecting the user_s benefit from the device.It could be assumed that the device did not cause or contribute to this outcome provided that this occurred ca.8 years after implantation and that the device is intended to remain implanted, being a reinsertion considered.Additionally, a complete active electrode insertion at implantation could not be yet determined.The clinic will monitor the user.

Event Description

The electrode lead can be seen in the external auditory canal.Access to sound with the device before this incident was normal, but afterwards the user did not respond to sound.No accident or trauma is reported.The user has no cochlear abnormalities or any medical history which might cause tissue breakdown.Also, there was no allegation against the device.The user will be monitored.Re-insertion is considered.

• 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: 9437176
• MDR Text Key: 169826113
• Report Number: 9710014-2019-00941
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737062682
• UDI-Public: (01)09008737062682
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR