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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user had an accident and the hearing performance with the device is affected.The user was explanted.
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the electrode array was accidentally pulled out of cochlea by the recipient.Device investigation revealed damage to the active electrode due to device minute mobility, possibly following the unintentional active electrode misplacement.Reportedly the recipient is handicapped and was manipulating the device in the middle ear with a sharp instrument, which might have contributed to the observed damages.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
Event or Problem Description
The user had an accident and the hearing performance with the device is affected.As per additional information, it is thought that the user opened the sutured auditory canal and penetrated a sharp object into the middle ear.When the object was further extended the entire electrode was pulled out of the cochlea through the skin suture into the external auditory canal.It is thought that this happened somewhere between the (b)(6) 2022 and the (b)(6) 2022.The device was explanted.The user won't be re-implanted, as further automanipulative behavior cannot be excluded.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: 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: 15410718
• Report Number: 9710014-2022-00672
• Device Sequence Number: 5512189
• Product Code: MCM
• UDI-Device Identifier: 09008737395438
• UDI-Public: (01)09008737395438
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/08/2023
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 39571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male