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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
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
Since implantation of the implant, 4 channels have been disabled due to being damaged because of multiple manipulations during electrode insertion.Now also channel 12 is disabled because of pain.The clinic is considering re-implantation with a new implant because the audiological and speech outcomes are not good.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, four apical channels show hi impedance since implantation, which indicates that the electrode has been damaged during implantation surgery.In addition, one channel has been left extra cochlea at the time of implantation, which might contribute to the lack of benefit.The concerned device was explanted, but has not been received for investigation yet.
Event or Problem Description
Since implantation of the implant, 4 channels have been disabled due to being damaged because of multiple manipulations during electrode insertion.Now also channel 12 is disabled because of pain.The user has been re-implanted on (b)(6) 2025.
Additional Manufacturer Narrative
Conclusion: based on the received information from the field, four apical channels show hi impedance since implantation due to a damage to the active electrode, which occured during implantation surgery.The damage was confirmed during device investigation.In addition, one channel has been left extra cochlea at the time of implantation and 2 more channels have been found extra-cochlear at the time of explantation, which might contribute to the lack of benefit.This is a final report.
Event or Problem Description
Since implantation of the implant, 4 channels have been disabled due to being damaged because of multiple manipulations during electrode insertion.Now also channel 12 is disabled because of pain.The user has been re-implanted on (b)(6) 2025.3 channels have been found extra-cochlear at explantation.

• 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: 21965513
• Report Number: 9710014-2025-00406
• Device Sequence Number: 18187127
• Product Code: MCM
• UDI-Device Identifier: 09008737369026
• UDI-Public: (01)09008737369026
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/30/2025

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: 05/01/2026
• Device Model Number: MI1250 SYNCHRONY 2
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 04/30/2025; 04/30/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/22/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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: 13 YR
• Patient Sex: Female