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

Model Number MI1000 MED-EL CONCERT PIN

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Undesired Nerve Stimulation (1980)

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

Reportedly, a ct scan showed that the electrode array is out of the cochlea.Revision surgery is considered.

Manufacturer Narrative

Additional information: according to the information received, the device was not providing enough benefit to the recipient and also causing non-auditory stimulation due to a partial post-operative active electrode migration out of the cochlea, as confirmed by post-operative diagnostic imaging.The concerned device was explanted but has not been received for investigation yet.

Event Description

Reportedly, a ct scan showed that the electrode array is out of the cochlea.The user has been re-implanted.Eight channels were found out from the cochlea at explantation.The concerned device has not yet been returned for investigation.

Manufacturer Narrative

Conclusions: 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.According to the information received, the device was not providing enough benefit to the recipient and also causing non-auditory stimulation due to a partial post-operative active electrode migration out of the cochlea, as confirmed by post-operative diagnostic imaging and during explantation surgery.This is a final report.

Event Description

The user presented facial nerve stimulation (fns) with stimulation on channels 7 to 12.The user has been re-implanted.

• 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: 14787904
• MDR Text Key: 295825096
• Report Number: 9710014-2022-00441
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737062675
• UDI-Public: (01)09008737062675
• 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,Followup,Followup
• Report Date: 11/23/2022

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: 05/11/2024
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 07676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 06/20/2022; 06/20/2022
• Supplement Dates FDA Received: 09/20/2022; 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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: 31 YR
• Patient Sex: Female