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

Model Number MI1210 SYNCHRONY ST

Device Problem Impedance Problem (2950)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

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.

Event Description

Approximately one month ago (b)(6) 2023), the user had a head trauma on the contra-lateral side.Despite this, the user continued to use the implant without interruption.One week ago (mid (b)(6) 2023), the user had an otitis infection on the contra-lateral side.The user attended a routine appointment on (b)(6) 2023, reporting no issues with the implant's functionality.During the appointment, an audiologist conducted a free field threshold audiometry test on both sides individually, yielding similar results for each ear: 20db, 20db, 15db, 20db, 15db, 15db, 15db, 15db.

Manufacturer Narrative

Additional information: based on the currently available information, damage to the reference electrode appears to be likely.However, to determine an exact root cause a device investigation of the explanted device would be necessary.Further technical and medical checks are considered but no date has been scheduled yet.

Event Description

Approximately one month ago (b)(6) 2023), the user had a head trauma on the contra-lateral side.Despite this, the user continued to use the implant without interruption.One week ago (b)(6) 2023), the user had an otitis infection on the contra-lateral side.The user attended a routine appointment on (b)(6) 2023, reporting no issues with the implant's functionality.Further medical intervention was considered.However, further proceedings are unknown.

• 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: 18398073
• MDR Text Key: 331823311
• Report Number: 9710014-2023-01148
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• 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
• Report Date: 02/13/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2023
• Device Model Number: MI1210 SYNCHRONY ST
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 12/27/2023
• Date Device Manufactured: 10/27/2020
• 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 Age: 8 YR
• Patient Sex: Male