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

Model Number MI1260 SONATA 2

Device Problem Impedance Problem (2950)

Patient Problems Ossification (1428); Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Event Description

The explanted device was received at headquarters.

Manufacturer Narrative

Conclusion: device investigation did not reveal any device defect or damage which has been present whilst implanted.Mechanical damages found are attributable to the removal surgery.Based on the information received from the field, affected channels, likely impedance fluctuations, were seen due to undetermined reasons.Further, ossification of the cochlea was reported, which might have contributed to the observed fluctuating impedances.This is a final report.

Event Description

The explanted device was received at headquarters.

• 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: 17369342
• MDR Text Key: 320171734
• Report Number: 9710014-2023-00632
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737385385
• UDI-Public: (01)09008737385385
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1260 SONATA 2
• Device Catalogue Number: 38548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2021
• 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: 5 YR
• Patient Sex: Male