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

Model Number MI1250 SYNCHRONY 2

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

Patient Problem Bacterial Infection (1735)

Event Date 07/21/2022

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 was implanted on the (b)(6) 2022.However it was then noticed in early (b)(6) that there was poor healing after implantation, with disunity at the bottom of the scar.There was an infection and extrusion of the device and cultures were positive for staphylococcus aureus.Therefore, it was decided to explant the device.The user was not activated before the device was explanted and the user will not be re-implanted within the next 6 months.

Manufacturer Narrative

Conclusions: according to the recipient report the device was explanted because of a post-operative infection at the incision site and wound healing issues with eventual extrusion of the device.A review of the devices sterilization records shows that the device has been subject to a valid sterilization process, thus no information available points to the implant being the source of the infection.However, a device contribution to the subsequent development of the infection and extrusion cannot be ruled out.In addition during device investigation damage to the active electrode caused by device minute mobility was found.Other mechanical damages are attributable to the removal surgery.This is a final report.

Event Description

The recipient was implanted on the (b)(6) 2022.However, it was then noticed in early july that there was poor healing after implantation, with dehiscence at the bottom of the scar.The recipient was not activated before the device was explanted.Therefore, it was decided to explant the device.

• 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: 15196994
• MDR Text Key: 297569353
• Report Number: 9710014-2022-00573
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737395414
• UDI-Public: (01)09008737395414
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 39569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• 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: 74 YR
• Patient Sex: Male