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); Migration (4003)

Patient Problems Inflammation (1932); Skin Tears (2516)

Event Date 03/23/2023

Event Type  Injury  

Event Description

It was initially reported that the user an inflammation and therefore the electrode was removed to clean it and then it was re-inserted.This revision surgery took place on (b)(6) 2023.It was later reported that the device housing was not found properly situated at the revision surgery.The electrode array was found fully inserted in the cochlea.At the revision surgery a new and deeper implant bed was created, away from the original implant bed.Reportedly there was inflammation of the skin due to the original poor location of the implant housing.Per op report there had been an extrusion of the implant in the retro-auricular region.Granulation was removed.

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Manufacturer Narrative

Conclusion: device investigation of the received parts did not reveal any device defect or problem which is expected to have been present whilst implanted.According to the information received from the field the recipient underwent a revision surgery due to an extrusion of the device through the skin.In addition during the revision surgery a dislocation of the implant housing from its intended position was observed.Furthermore, the implant area was found to be infected.During the revision surgery, the infection was cleaned and the device fixated properly.However, the observed infection re-occurred leading to explantation of the device.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.No information available points to the implant being the source of the infection.This is a final report.

Event Description

Initial information was received that the user had a large inflammation and therefore at a revision surgery the electrode was removed to clean it and then it was re-inserted.This revision surgery took place on (b)(6) 2023.However, additional information gathered later indicated that there was an infection of the implant bed and dislocation of the device housing.The device housing was not found properly situated at the revision surgery.Per op report there had been an extrusion of the implant in the retro-auricular region and granulation tissue was removed.The electrode array was found fully inserted in the cochlea.No cultures were taken.At the revision surgery a new and deeper implant bed was created, away from the original implant bed.Reportedly there was inflammation of the skin due to the poor location of the implant housing.Two months after revision surgery, the user is bleeding behind the ear, the inflammation is back again.Thus, the user has been explanted.

• 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: 16681374
• MDR Text Key: 312684746
• Report Number: 9710014-2023-00277
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737395452
• UDI-Public: (01)09008737395452
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• 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: 39573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2021
• 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: 59 YR
• Patient Sex: Female