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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
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 device was explanted in an emergency surgery on 01-may-2024.Reportedly, there was a wound over the implant.More details to follow.Re-implantation is being considered.No date has been scheduled yet.
Event or Problem Description
The device was explanted in an emergency surgery on (b)(6) 2024.Reportedly, there was a wound over the implant.Re-implantation is not being considered at the moment due to the user's skin problems which are thought to be caused by tinea capitis disease.
Additional Manufacturer Narrative
Conclusion: device investigation of the received parts did not reveal any device defect or damage which is as expected as the device was explanted due to repeated implant site infections with skin dehiscence, necrosis and extrusion.The user has a history of radiotherapy to the skull as a child and has current diagnosis of tinea capitis, which is thought to have contributed to the reported skin problems.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process, therefore it is unlikely that it was the source of the infection, but device contribution to its severity cannot be excluded.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: 19339516
• Report Number: 9710014-2024-00439
• Device Sequence Number: 15638355
• Product Code: MCM
• UDI-Device Identifier: 09008737094003
• UDI-Public: (01)09008737094003
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/05/2021
• Device Model Number: MI1200 SYNCHRONY
• 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: 05/02/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2018
• 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: 76 YR
• Patient Sex: Female