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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A message from the user on the med-el social media blog was received in which the user complains about difficulties in hearing with using the implant.She reports that she is not able to hear voices, she hears only sounds and noises.She also reports to hear like bells ringing sometimes and would also hear sounds when not wearing the audio processor or when touching her pinna.
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
A message from the user on the med-el social media blog was received in which the user complains about difficulties in hearing with using the implant.The user reports not to be able to hear voices, only sounds and noises.The user also reports hearing bell like ringing sometimes and also hears sounds when not wearing the audio processor or when touching her pinna.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the device did not provide sufficient benefit due to a migration of the active electrode out of cochlea.According to the implant registration card a complete insertion was achieved at implantation surgery.No information on possible further steps has been received.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the device did not provide sufficient benefit due to a migration of the active electrode out of cochlea.According to the implant registration card a complete insertion was achieved at implantation surgery.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The user complains about difficulties in hearing with using the implant.The user was re-implanted on (b)(6) 2025.

• 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: 17276640
• Report Number: 9710014-2023-00574
• Device Sequence Number: 12089672
• Product Code: MCM
• UDI-Device Identifier: 09008737331863
• UDI-Public: (01)09008737331863
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2025

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: 08/13/2021
• Device Model Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 33337
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 06/28/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 10/03/2023; 07/02/2025
• Date Device Manufactured: 08/13/2018
• 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: 54 YR
• Patient Sex: Female