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

Model Number	MI1260 SONATA 2
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The recipient had a skin infection at the implant site, namely skin necrosis.1 month of antibiotic therapy was provided.However, the device was visible through the wound.Moreover, the surgical wound completely healed after implantation.The recipient has been explanted.Re-implantation is scheduled for (b)(6) 2024.
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.
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 an infection at the implant site with necrosis and device extrusion that did not respond to antibiotic treatment.Positive cultures for pseudomonas aeruginosa were found.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.Therefore the device does not appear to be the source of the infection, but rather perioperative inoculation of bacteria through the skin.But its contribution to the severity of the infection cannot be ruled out.This is a final report.
Event or Problem Description
The recipient had a skin infection with necrosis at the implant site and was treated with antibiotics for 1 month.The device was visible through the wound.Reportedly, the surgical wound completely healed after initial implantation.The recipient has been explanted.The recipient has been implanted on the contra-lateral side.

• 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: 19369443
• Report Number: 9710014-2024-00459
• Device Sequence Number: 7619065
• Product Code: MCM
• UDI-Device Identifier: 09008737385446
• UDI-Public: (01)09008737385446
• 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: 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): 08/21/2024

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 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: 05/16/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2023
• 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: 35 MO
• Patient Sex: Male