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

Model Number	SONATA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	04/04/2024
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 recipient was implanted in 2022, however, due to repeated infections on top of the received, the recipient was not able to wear the audio processor.Therefore, decision to explant the device was made.Hearing performance also degraded as the child was not able to use the audio processor.Furthermore, the recipient was treated with iv antibiotics and daily wound site dressing.However, for type of infection it was mentioned by surgeon as bacterial biofilm formation.The recipient has been explanted.
Event or Problem Description
The recipient was implanted in 2022, however, due to repeated infections on top of the receiver, the recipient was not able to wear the audio processor.Therefore, decision to explant the device was made.Hearing performance also deteriorated as the child was not able to use the audio processor.The recipient has been explanted.
Additional Manufacturer Narrative
Additional information: in-situ measurements point to a functional implant.This is as expected as the device was explanted due to recurrent skin flap infections.Cultures showed a significant growth of methicillin sensitive staphylococcus aureus.Review of device sterilization records show that the device has been subject to a valid sterilization process.Thus, it is unlikely that the device was the cause of the infection, however its contribution to its severity cannot be ruled out.

• 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: 19727711
• Report Number: 9710014-2024-00618
• Device Sequence Number: 8147775
• Product Code: MCM
• UDI-Device Identifier: 09008737049171
• UDI-Public: (01)09008737049171
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/08/2024

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: 12/15/2024
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 10/08/2024
• Date Device Manufactured: 12/15/2021
• 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: 7 YR
• Patient Sex: Female