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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9710014-2023-01129
• Device Sequence Number: 7912584
• Product Code: MCM
• UDI-Device Identifier: 09008737395377
• UDI-Public: (01)09008737395377
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/28/2025
• Device Model Number: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male