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

Model Number MI1200 SYNCHRONY PIN

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 10/21/2021

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

On (b)(6) 2021 the programming audiologist reported that the user had an emergency visit and can no longer hear with his sonnet processor.Ci externals were checked and appeared to be in good working condition.A virtual consultation in january is planned.

Event Description

In situ measurements showed affected channels and on the 22nd december the user could no longer hear with the device.The user would like to proceed with re-implantation but there are health concerns.

Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is plausible.However to determine an exact root cause a device investigation of the explanted device is necessary.Further, the recipient reports csf leakage from the eye and the nose that was also occurring prior to implantation.The reported symptoms are most likely caused by device unrelated medical reasons, namely branchio oto renal syndrome (bor).Re-implantation is considered but no date has been scheduled yet.

• 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: 13083624
• MDR Text Key: 283434586
• Report Number: 9710014-2021-01065
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737310868
• UDI-Public: (01)09008737310868
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

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: 03/09/2017
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 12/24/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2015
• 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: 49 YR