MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number	SONATA
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user was activated in (b)(6) 2022.Around that time there was a slight discharge coming from the scar.The surgeon prescribed antibiotics.Afterwards, she was able to wear her processor and was satisfied.In (b)(6) 2023, the problem reoccurred and in the beginning of (b)(6), the clinician saw clearly the beginning of extrusion of the implant.
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.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient underwent a revision surgery due to an extrusion of the device though the skin in the post-operative period.However, after the revision surgery the wound did not heal and the device extruded again.A review of the device_s sterilization records show that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of the reported issue.However, a device contribution to the subsequent development of the extrusion cannot be ruled out.Explantation is planned but no date has been scheduled yet.
Event or Problem Description
The user was activated in (b)(6) 2022.Around that time there was a slight discharge coming from the scar.The surgeon prescribed antibiotics.Afterwards, she was able to wear her processor and was satisfied.In (b)(6) 2023, the problem reoccurred and in the beginning of july, the clinician saw clearly the beginning of extrusion of the implant.Revision surgery has been performed on (b)(6) 2023, where the device was repositioned 2 cm from the initial position.The electrode array migrated out of cochlea during surgery, however, was re-inserted after re-drilling of posterior tympanotomy and rw opening.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• 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: 17377022
• Report Number: 9710014-2023-00633
• Device Sequence Number: 6685145
• Product Code: MCM
• UDI-Device Identifier: 09008737049133
• UDI-Public: (01)09008737049133
• 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: 2022
• 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): 01/22/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SONATA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 01/22/2024
• 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: 48 YR
• Patient Sex: Female