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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Failure of Implant (1924)
Date of Event	04/21/2024
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
It was reported that the user underwent revision a few days after implantation due to csf leakage to close the sealing.A hematoma was present as well.During the revision surgery, the electrode array was found outside the cochlea.
Event or Problem Description
It was reported that the user underwent revision a few days after implantation due to csf leakage to close the sealing.A hematoma was present as well.During the revision surgery, the electrode array was found outside the cochlea.Reimplantation with a form electrode is being considered due to possible damage to the active electrode.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient underwent a revision surgery due to csf leakage in the post-operative period.Reportedly during the revision surgery the electrode was found extra-cochlear due to a migration of the active electrode.After the revision surgery in situ measurements show nine channels with hi status likely due to a damage, which occurred during revision surgery.Re-implantation is planned but no date has been scheduled yet.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient underwent a revision surgery due to csf leakage in the post-operative period.Reportedly during the revision surgery the electrode was found extra-cochlear due to a migration of the active electrode.After the revision surgery in situ measurements show nine channels with hi status.Device investigation revealed fatigue wire breakages in the active electrode, which goes in line with the received in situ measurements.This is a final report.
Event or Problem Description
It was reported that the user underwent revision a few days after implantation due to csf leakage to close the sealing.A hematoma was present as well.During the revision surgery, the electrode array was found outside the cochlea.The user was reimplanted.

• 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: 19489457
• Report Number: 9710014-2024-00511
• Device Sequence Number: 12534993
• Product Code: MCM
• UDI-Device Identifier: 09008737366742
• UDI-Public: (01)09008737366742
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2024

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: 08/24/2026
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 06/04/2024; 06/04/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 09/03/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• 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: 17 MO
• Patient Sex: Male