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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user has had poorer performance than expected since activation.Patient has reported abnormal sound quality mumbling with no clarity of speech.Also reports pinging when touching pinna and with jaw movements.There was some pain in the temple that has resolved.All external equipment is functional.In situ measurements in (b)(6) 2025 revealed no technical problems.Ct confirmed 4 extra-cochlear channels.Reportedly, a full insertion was achieved at implantation.Re-insertion or revision surgery is recommended.
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, the device is not providing sufficient benefit to the recipient due to a post-operative active electrode migration out of the cochlea, as confirmed by post-operative diagnostic imaging.Further, the recipient experienced temporary pain in the head, which was resolved.Revision surgery was scheduled but has been postponed.
Event or Problem Description
The user has had poorer performance than expected since activation.Patient has reported abnormal sound quality mumbling with no clarity of speech.Also reports pinging when touching pinna and with jaw movements.Re-insertion was scheduled but has been postponed.
Additional Manufacturer Narrative
Additional information: according to the information received, the device is not providing sufficient benefit to the recipient due to a post-operative active electrode migration out of the cochlea, as confirmed by post-operative diagnostic imaging.The reported facial nerve stimulation was likely caused by extra-cochlear stimulation due to the electrode migration.Further, the recipient experienced temporary pain in the head, which was resolved.Re-insertion of the electrode was performed successfully.The device remains implanted and in use.
Event or Problem Description
The user has had poorer performance than expected since activation and facial stimulation.Patient has reported abnormal sound quality mumbling with no clarity of speech.Also reports pinging when touching pinna and with jaw movements.Re-insertion was successfully performed.The facial nerve was dehiscent in the facial recess.The surgeon placed a bit of tissue over the facial nerve to protect it.

• 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: 23847855
• Report Number: 9710014-2025-01190
• Device Sequence Number: 21214229
• Product Code: MCM
• UDI-Device Identifier: 09008737395445
• UDI-Public: (01)09008737395445
• 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: 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): 03/03/2026

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 PIN
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 12/17/2025
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/03/2026; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 58 YR
• Patient Sex: Male