MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH CONCERTO; COCHLEAR IMPLANT

Model Number MI1050 MED-EL CONCERT 2 PIN

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

During a routine mapping on (b)(6) 2024 high impedances were observed in 10-11 channels.Further proceeding is currently unknown.

• Brand Name: CONCERTO
• 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: 18987796
• MDR Text Key: 338725495
• Report Number: 9710014-2024-00288
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737400415
• UDI-Public: (01)09008737400415
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1050 MED-EL CONCERT 2 PIN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Date Device Manufactured: 10/24/2022
• 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 Age: 22 MO
• Patient Sex: Female