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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user's hearing performance with the device is affected.The user had an epileptic seizure and fell on her head.She then had a different auditory impression.The user was re-implanted on (b)(6) 2025.
Additional Manufacturer Narrative
The device has been explanted and 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 had an epileptic seizure and fell on her head.She then had a different auditory impression.The user was re-implanted on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: according to the available information, damage to the active electrode likely due to minute device mobility, caused by the reported impact, which might have weakened the electrode fixation, is suspected.In addition, a full insertion could not be achieved at the implantation surgery.Re-implantation was carried out, but the device has not been received for investigational purposes yet.
Event or Problem Description
The user had an epileptic seizure and fell on her head.She then had a different auditory impression.The user was re-implanted on (b)(6) 2025.
Additional Manufacturer Narrative
Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.Also, the reported impact to the head might have weakened the fixation of the active electrode and could also be a factor for electrode mobility.In addition, a full insertion could not be achieved at the implantation surgery.The problems given in the recipient report appear to match the damage found.This is a final report.

• 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: 21897090
• Report Number: 9710014-2025-00357
• Device Sequence Number: 16995619
• Product Code: MCM
• UDI-Device Identifier: 09008737395414
• UDI-Public: (01)09008737395414
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Literature
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2025

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: 03/18/2024
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 04/14/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/02/2025; 07/14/2025
• 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: 43 YR
• Patient Sex: Female