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

Model Number MI1250 SYNCHRONY 2

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 11/28/2023

Event Type  malfunction  

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 experienced migration of the stimulator from the implant bed towards the mastoid cavity, leading to pain and thinning of the skin over the implant.During a revision surgery to reposition the stimulator, the electrode lead was accidentally damaged.The mastoid cavity showed significant fibrosis, and the electrode lead was also found to be kinked.While attempting to remove the fibrosis, the surgeon caused further damage to the lead, so the implant had to be replaced.

Event Description

The user experienced migration of the stimulator from the implant bed towards the mastoid cavity, leading to pain and thinning of the skin over the implant.The mastoid cavity showed significant fibrosis, and the electrode lead was also found to be kinked.While attempting to remove the fibrosis, the surgeon damaged the electrode lead, so the implant had to be replaced.

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 revision surgery.According to the information received from the field the recipient underwent a revision surgery due to a migration of the implant housing from its intended position.During the revision surgery the device was inadvertently damaged and therefore explanted.Additionally, in situ measurements whilst implanted show one short circuit due to unknown reasons.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: 18362500
• MDR Text Key: 330960787
• Report Number: 9710014-2023-01129
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2022
• 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: 51 YR
• Patient Sex: Male