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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Breakdown (2681)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
Event or Problem Description
On (b)(6) 2024, the user was scheduled for a revision surgery.During the surgery it was discovered that the active electrode array had completely come out of the cochlea and was visible outside the skin and pinna.The user suffered from a skin problem, which caused the wound and tissue to open, and it appeared that the user had pulled out the electrode cable.Consequently, the active electrode array became dislodged from the cochleostomy, resulting in hearing loss.The medical team suspects that an active infection may have contributed to the wound opening.Additionally, there were signs of an infection observed during the surgery, with the implant being covered by fibrotic tissue within a tissue bag.A new device was implanted as a precaution against infection and due to extrusion of the electrode array.The activation of the new device is scheduled to take place in one month after the medical assessment.
Additional Manufacturer Narrative
Conclusion: 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.According to the information received from the field the device was explanted due to an infection and extrusion of the electrode through the skin, leading to the active electrode being pulled out of cochlea.During explantation surgery the active electrode array was found completely out of the cochlea and visible outside the skin and pinna.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 infection.However, the presence of the device might have contributed to its subsequent development.This is a final report.
Event or Problem Description
The user's hearing performance with the device was affected.On (b)(6) 2024, the user was scheduled for a revision surgery.During the surgery it was discovered that the active electrode array had completely come out of the cochlea and was visible outside the skin and pinna.The user suffered from a skin problem, which caused the wound and tissue to open, and it appeared that the user had pulled out the electrode cable.Consequently, the active electrode array became dislodged from the cochleostomy, resulting in hearing loss.The medical team suspected that an active infection may have contributed to the wound opening.Additionally, there were signs of an infection observed during the surgery, with the implant being covered by fibrotic tissue within a tissue bag.Technical checks before the surgery confirmed that the implant was functioning properly.Moreover, it was reported that the surgical wound healed completely after implantation.The user was reimplanted with a new device as a precaution against infection and due to extrusion of the electrode array.

• 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: 19069356
• Report Number: 9710014-2024-00330
• Device Sequence Number: 17865266
• 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: 2023
• 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): 05/23/2024

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: 02/05/2026
• Device Model Number: MI1260 SONATA 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2023
• 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: 56 YR
• Patient Sex: Male