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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a fitting session, it was not possible to run the in-situ measurements because of an error message from the maestro software saying that the device was not detected.The audio processor dl-coil, the max s-coil and the coupling check tool were tried.It was also tried to use a different max and a different laptop, but the result was still the same (reportedly: "any feedback of the internal part").The external part was checked, and everything was working.The user does not have hearing sensation on the concerned left side, as also confirmed by the audiometric test.A ct-scan is scheduled on (b)(6)2025 to evaluate the implant placement and after that, the clinic will decide when to proceed with re-implanting the user.
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
Additional information: according to the information received from the field a technical implant failure seems likely.In addition in situ measurements showed two channels with hi status due to undetermined reasons.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
During a fitting session, it was not possible to run the in-situ measurements because of an error message from the maestro software saying that the device was not detected.The audio processor's dl-coil, the max s-coil and the coupling check tool were tried.A different max and a different laptop were also tried, but the result was still the same.The external part was checked, and everything was working.The user does not have hearing sensation on the concerned left side, as also confirmed by the audiometric test.Reimplantation is considered but not date has been scheduled as yet.
Event or Problem Description
During a fitting session, it was not possible to run the in-situ measurements because of an error message from the maestro software saying that the device was not detected.The audio processor's dl-coil, the max s-coil and the coupling check tool were tried.A different max and a different laptop were also tried, but the result was still the same.The external part was checked, and everything was working.The user does not have hearing sensation on the concerned left side, as also confirmed by the audiometric test.The user has been re-implanted.
Additional Manufacturer Narrative
Additional information: according to the information received from the field a technical implant failure seems likely.In addition, in situ measurements showed two channels with hi status due to undetermined reasons.The concerned device was explanted but has not been received for investigation yet.

• 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: 21430524
• Report Number: 9710014-2025-00177
• Device Sequence Number: 4349155
• Product Code: MCM
• UDI-Device Identifier: 09008737395414
• UDI-Public: (01)09008737395414
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/10/2025

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 Model Number: MI1250 SYNCHRONY 2
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 02/18/2025; 02/18/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/22/2025; 06/10/2025
• Date Device Manufactured: 02/28/2024
• 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: 6 YR
• Patient Sex: Female