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

Model Number MI1250 SYNCHRONY 2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 02/20/2023

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 suffered from mastoiditis and labyrinthitis in the implant housing region.The device was explanted.

Event Description

The user had mastoiditis and labyrinthitis in the implant housing region.Cultures confirmed staphylococcus aureus (non mrsa).The user had already reported pain and discomfort 2 weeks post-operatively and swelling around the implant housing from around 4-5 weeks post-op.The pain subsided, the middle ear showed no symptoms of inflammation and there was no local discoloration or heightened sensitivity.The device was explanted, the recipient might be re-implanted at a later date (3 months).A placeholder was left in the cochlea for later re-implantation (insertion electrode, not med-el brand).

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.This finding was expected, because according to the received information the device was explanted due to mastoiditis.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 device being the source of infection, which was rather possibly related to peri-operative contamination.This is a final report.

• 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: 16767515
• MDR Text Key: 313557239
• Report Number: 9710014-2023-00330
• Device Sequence Number: 1
• Product Code: MCM
• 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: 07/07/2023

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?: No
• 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
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 44 YR
• Patient Sex: Male