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

Model Number SONATA

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Tissue Breakdown (2681)

Event Date 12/13/2023

Event Type  Injury  

Event Description

The parents reported on (b)(6) 2023, that swelling and redness were seen over the implant site.The recipient was suggested to stop wearing the audio processor (ap) for a while to see if the edema could be resolved.After about 15 days, the recipient recovered from the edema and started to wait the ap again.However, on (b)(6) 2023 the parents reported that the edema occurred again and overtime gradually turned into ulceration.Furthermore, the implant started to extrude.Moreover, effusion draining was performed, the fluid was reddish-brown, but fluid check was not conducted.The recipient has been explanted.Re-implantation is considered after the skin flap healed.

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.

Manufacturer Narrative

Conclusion: device investigation of the received parts 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.According to the information received from the field the device was explanted due to a swelling and extrusion of the device through the skin.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 any infection.However, a device contribution to the subsequent development of the extrusion cannot be ruled out.This is a final report.

Event Description

The parents reported on (b)(6) 2023, that swelling and redness were seen over the implant site.The recipient was suggested to stop wearing the audio processor (ap) for a while to see if the edema could be resolved.After about 15 days, the recipient recovered from the edema and started to wait the ap again.However, on 01-sep-2023 the parents reported that the edema occurred again and overtime gradually turned into ulceration.Furthermore, the implant started to extrude.Moreover, effusion draining was performed, the fluid was reddish-brown, but fluid check was not conducted.The recipient has been explanted and re-implanted at a later date.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: 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: 18397142
• MDR Text Key: 331363369
• Report Number: 9710014-2023-01146
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737083618
• UDI-Public: (01)09008737083618
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/26/2023
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 MO
• Patient Sex: Female