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); Migration (4003)

Patient Problem Failure of Implant (1924)

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

Affected channels have been observed during in situ testing.The user has an abnormal skin growth behind the pinna above the electrode lead and located on the pinna.

Manufacturer Narrative

Additional information: according to the received information from the field, the active electrode migrated partially out of cochlea post-operatively.Additionally, two channels were already left outside of cochlea during implantation surgery.Reportedly only seven channels are currently available for stimulation.In addition, keloid growth behind the pinna was observed, which is likely due to device unrelated medical reasons.Surgical procedure is considered to manage the observed issues; however no date has been scheduled yet.

Event Description

The recipient has an abnormal skin growth behind the pinna above the electrode lead and located on the pinna.Affected channels have been observed during in situ testing.However, the hearing performance using the device seems not to be affected.It is planned to implant the contralateral side and if possible, in the same surgery to remove the skin growth and try to re-insert the electrode on the concerned side.But the date of surgery has not been scheduled yet.

• 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: 10868267
• MDR Text Key: 217152539
• Report Number: 9710014-2020-00683
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• 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: 11/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR