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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the electrode migrated from the cochlea which was confirmed by imaging leading o a revision surgery.During the repositioning surgery, the firm electrode lead was encased by tissue on the upper mastoidectomy.Small movements of the tissue, caused by the surgical instruments, showed shifting movements on the lower part of the lead towards the posterior tympanotomy.No fixation clip could be used initially due to the anatomy.During the exposure of the implant bed, the outgoing lead was most likely damaged by the surgeon.Therefore, the user was reimplanted with a new device in the same surgery.
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
It was reported that the electrode migrated from the cochlea which was confirmed by imaging leading o a revision surgery.During the repositioning surgery, the firm electrode lead was encased by tissue on the upper mastoidectomy.Small movements of the tissue, caused by the surgical instruments, showed shifting movements on the lower part of the lead towards the posterior tympanotomy.No fixation clip could be used initially due to the anatomy.During the exposure of the implant bed, the outgoing lead was most likely damaged by the surgeon.Therefore, the user was reimplanted with a new device in the same surgery.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient underwent a revision surgery due to a migration of the electrode out of cochlea.During the re-insertion surgery the device was inadvertently damaged.The reported damage was confirmed during device investigation.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: 19496222
• Report Number: 9710014-2024-00514
• Device Sequence Number: 20985653
• Product Code: MCM
• UDI-Device Identifier: 09008737395476
• UDI-Public: (01)09008737395476
• 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: 2023
• 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
• Report Date (Section B): 07/22/2024

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: 06/06/2025
• 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
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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: 29 YR
• Patient Sex: Male