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

Model Number MI1200 SYNCHRONY

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 10/13/2023

Event Type  Injury  

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 Description

The user has a wound infection.The infection was first reported on (b)(6) 2023.Treatment included infusion and wound cleaning.When cleaning of the wound was stopped, pus started to discharge.Thus, the device was explanted.The housing was dislocated from implant bed and migrated behind the ear.The device was explanted on (b)(6) 2023.

Manufacturer Narrative

Conclusion: device investigation did not reveal any device defect or damage.According to the information received from the field the device was explanted due to an infection at the implant site in the post-operative period.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of infection.Further the implant housing migrated form its intended position.In addition one channel was found extra-cochlear at explantation surgery due to a post-operative migration of the electrode.This is a final report.

Event Description

The user had a wound infection reported on (b)(6) 2023.Treatment involved infusion, wound cleaning, and eventually explantation due to pus discharge.The skin over the device was damaged, and the housing dislocated and migrated behind the ear.The surgical wound had fully healed after the initial implantation.The device was explanted on (b)(6) 2023.The wound was filled with infected granulation tissue.

• 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: 18028677
• MDR Text Key: 326834773
• Report Number: 9710014-2023-00964
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094041
• UDI-Public: (01)09008737094041
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• 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: 16 MO
• Patient Sex: Female