MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SYNCHRONY; COCHLEAR IMPLANT

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The user complained of a change in sound quality and a sensation of a tickling in his right ear canal.The sound quality in the right ear has been reported as very high-pitched with a buzzing quality.Anyway the user still feels that hearing is better with the device than without it.The electrode array was then visualised in the user's ear canal.According to the implant registration card a full insertion of the flex20 array was not achieved and 1 channel was left extra-cochlear.The user will visit the implanting surgeon and a ct will be performed.
Event or Problem Description
The user complained of a change in sound quality and a sensation of a tickling in his right ear canal.The sound quality in the right ear has been reported as very high-pitched with a buzzing quality.The electrode array was then visualised in the user's ear canal, where an extrusion is suspected.A ct scan showed that the excess lead has extruded into the ear canal, however, the electrode is still secure in the cochlea in its original surgical position.The user still feels that hearing is better with the device than without it.A revision surgery will not be performed, the plan is instead to address sound quality issues with programming.The user will return for follow-up testing and mapping; however it has currently been postponed due to illness.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the electrode lead extruded into the external auditory canal.The recipient has a history of previous ear surgeries, including an ear canal closure, which might have contributed to the current event.Imaging confirmed that the electrode array is still in the cochlea.One channel was left extra-cochlear during implantation surgery due to unexpected ossification.Additionally, sound quality issues which are reported will be addressed with re-programming by the clinic.Currently no surgical intervention is considered and the device stays implanted and in use.
Additional Manufacturer Narrative
Based on the received information from the field, the electrode lead extruded into the external auditory canal.The recipient has a history of previous ear surgeries, including an ear canal closure, which might have contributed to the current event.Imaging confirmed that the electrode array is still in the cochlea.One channel was left extra-cochlear during implantation surgery due to unexpected ossification.In addition, in situ measurements show ten channels with hi channels likely caused by damage to the active electrode caused by excessive mechanical stress.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The user complained of a change in sound quality and a sensation of a tickling in his right ear canal.The sound quality in the right ear has been reported as very high-pitched with a buzzing quality.The electrode array was then visualised in the user's ear canal.The user still feels that hearing is better with the device than without it.The user has been re-implanted on (b)(6) 2024.

• Brand Name: SYNCHRONY
• 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: 15500334
• Report Number: 9710014-2022-00723
• Device Sequence Number: 11210431
• Product Code: MCM
• UDI-Device Identifier: 09008737371746
• UDI-Public: (01)09008737371746
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/23/2022
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 37180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 09/09/2022; 09/09/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 01/31/2023; 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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: 70 YR
• Patient Sex: Male