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

Model Number MI1000 MED-EL CONCERT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Seroma (2069)

Event Date 08/05/2021

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 user has been explanted on (b)(6) 2021 upon user request and due to medical reasons.The user will be seen again on (b)(6) 2022.

Manufacturer Narrative

Conclusion: the received information from the field states, that no evident infection signs were observed at explantation and no obvious predisposing factors were reported.The recurrent aseptic exudate was therefore most likely due to a local foreign body formation, which finally led to granulation tissue that exerted forces on the device over time.Additionally, one channel was fluctuating in and out of high impedance status for unknown reasons.Investigation of the received parts showed that the device works within normal limits.Mechanical damages found are attributable to the removal surgery.This is a final report.

Event Description

The recipient has been explanted on (b)(6) 2021 upon request and due to medical reasons.It was initially reported that the explantation was due to recurrent hematoma on the right side of the head.However, it was clarified on (b)(6) 2021 that the recipient had a recurrent seroma instead.The recipient received good benefit from the device.The recipient was re-implanted on (b)(6) 2022.As per latest information received on 01-feb-2022, the user is happy with the new device after reactivation.There is no sign of infection on either side at the moment.

• 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: 12974566
• MDR Text Key: 282032012
• Report Number: 9710014-2021-01010
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737062682
• UDI-Public: (01)09008737062682
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2014
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2012
• 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: 19 YR
• Patient Sex: Female