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

Model Number MI1000 MED-EL CONCERT

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The device along with the derf have been received to hq.Per device explantation report form information, the symptoms/ conditions that lead to explantation were pain below the implant, headache and tinnitus.It was also reported the user had bad sound perception and no speech perception with the device.The reported pain was still present with wearing the device even when no stimulation was applied.The user had a prolonged period of deafness prior to implantation.

Manufacturer Narrative

Conclusion: based on the received information, the recipient did not sufficiently benefit from the implant system and reported pain and tinnitus leading to explantation.These symptoms are known post-operative side-effects of ci implantation.During device investigation the device operates within specification.The recipient has not been re-implanted.This is a final report.

Event Description

The device has been received for investigation.According to the explant report the recipient was explanted due to pain below the implant, tinnitus and headache.The pain was also present when the audio processor was worn but not switched on.The recipient had bad sound perception and no speech perception with the device.The recipient decided to not be re-implanted with a new device.

• 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: 10683617
• MDR Text Key: 211468730
• Report Number: 9710014-2020-00592
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737083632
• UDI-Public: (01)09008737083632
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 08842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• 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: 81 YR