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

Model Number MI1260 SONATA 2

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681)

Event Date 03/25/2024

Event Type  Injury  

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 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.

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 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
• 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: 19069356
• MDR Text Key: 339673044
• Report Number: 9710014-2024-00330
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737385439
• UDI-Public: (01)09008737385439
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 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
• Device Operator: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2023
• 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: 56 YR
• Patient Sex: Male