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

Model Number	MI1260 SONATA 2
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Migration (4003)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
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
A revision surgery was scheduled for (b)(6) 2024 due to the migration of the device to the posterior part of the pinna.During preparations for the surgery, an extrusion of both the implant stimulator and the electrode cable was detected.The repositioning of the implant was planned, however, post infection signs were present in the tissue surrounding the implant.During the opening of the wound the electrode lead exit was accidentally cut, so a new device had to be re-implanted.The user's audio processor will be activated next month provided that the medical status permits.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the implant housing started to migrate from its intended position one month after initial activation.Subsequently the device extruded due to pressure applied to the skin caused by the migrated housing.During revision surgery signs of infection were noticed and an extrusion of the electrode lead into the eac was observed.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of the infection.Device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.This is a final report.
Event or Problem Description
It was reported that the device migrated from its intended position to the posterior part of the pinna starting one month after the use of the external device.The surgical wound after initial implantation healed properly.During preparations for the revision surgery, an extrusion of both the implant stimulator and the electrode lead was detected.During the surgery post infection signs have been observed in the tissue surrounding the implant.Reportedly the extrusion was caused by the pressure applied by the stimulator housing on the skin.Infection is thought to has occurred due to the extrusion.During the opening of the wound the electrode lead exit was accidentally cut and a back-up device was implanted.

• Brand Name: SONATA
• 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: 19526437
• Report Number: 9710014-2024-00526
• Device Sequence Number: 20753322
• Product Code: MCM
• UDI-Device Identifier: 09008737385439
• UDI-Public: (01)09008737385439
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 03/30/2026
• Device Model Number: MI1260 SONATA 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: 06/06/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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: 66 YR
• Patient Sex: Female