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

Model Number SONATA

Device Problems Malposition of Device (2616); Output Problem (3005); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it is to 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 has not developed auditory skills.

Event Description

The user has not developed auditory skills.

Manufacturer Narrative

Additional information: according to the information received, the user has limited benefit with the device.Reportedly, a complete insertion of the electrode array could not be achieved at implantation despite no cochlea-vestibular malformation being observed.Diagnostic imaging and objective measurements confirmed 3 to 4 electrode contacts being extra-cochlea, which were disabled from the beginning of the rehabilitation.The reported lack of benefit appears to be due to the reported insufficient insertion depth.Received in situ measurements are indicative of a fully functional device.Despite requested, no information on possible further steps has been received.

Manufacturer Narrative

Additional information: according to the information received, the recipient had limited benefit with the device.Reportedly, a complete insertion of the electrode array could not be achieved at implantation despite no cochlea-vestibular malformation being observed.Diagnostic imaging and objective measurements confirmed 3 to 4 electrode contacts being extra-cochlear, which were disabled from the beginning of the rehabilitation.The reported lack of benefit appears to be due to the reported insufficient insertion depth.The concerned device was explanted but has not been received for investigation yet.

Event Description

It was reported that the user has not developed auditory skills.Limited auditory and language skill from the beginning of the rehabilitation were reported, after the four most basal electrode contacts were disabled.The user has been re-implanted.

Manufacturer Narrative

Conclusion: device investigation of the received parts did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received, the recipient had limited benefit with the device.Reportedly, a complete insertion of the electrode array could not be achieved at implantation despite no cochlea-vestibular malformation being observed.Diagnostic imaging and objective measurements confirmed 3 to 4 electrode contacts being extra-cochlear, which were disabled from the beginning of the rehabilitation.The reported lack of benefit appears to be due to the reported insufficient insertion depth.This is a final report.

Event Description

It was reported that the user has not developed auditory skills.Limited auditory and language skill from the beginning of the rehabilitation were reported, after the four most basal electrode contacts were disabled.The user has been re-implanted with a shorter electrode.

• 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: 11483641
• MDR Text Key: 242213718
• Report Number: 9710014-2021-00171
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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,Followup,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/05/2019
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2016
• 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: 9 YR
• Patient Sex: Male