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

Model Number SONATA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

On (b)(6) 2022 the user was picking her ears and accidentally pulled out the electrode array.On (b)(6) 2023 the revision surgery for the external auditory canal and re-implantation took place.

Manufacturer Narrative

Conclusion: according to the information received from the field the recipient accidentally pulled the electrode out of cochlea.Reportedly, beforehand the electrode lead has extruded through the tympanic membrane likely due to a reported otitis media.In addition, during device investigation damage to the active electrode caused by device minute mobility causing fatigue wire breakages was found.Other mechanical damages found are attributable to the removal surgery.This is a final report.

Event Description

On 12-sep-2022 the user was picking her ears and accidentally pulled out the electrode array.Reportedly, the electrode lead had penetrated the ear drum.It has been suspected that the user suffered from otitis media which has led to the perforation of the ear drum before the event occurred.On (b)(6) 2023 the revision surgery for the external auditory canal and re-implantation took place.

• 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: 16193719
• MDR Text Key: 307562779
• Report Number: 9710014-2023-00045
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737042103
• UDI-Public: (01)09008737042103
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2016
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2014
• 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: 10 YR
• Patient Sex: Female