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 Unspecified Ear or Labyrinth Problem (4474); Insufficient Information (4580)

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

The user presented to the surgeon with reports of decreased hearing performance with the device.

Manufacturer Narrative

Additional information: according to the information received, the recipient experienced sudden decrease in hearing ability both in the implanted and non-implanted ear, following one session of hyperbaric oxygen treatments (hbot), during which central nervous system oxygen toxicity occurred.In situ measurements performed prior and after hbot are stable and indicative of a functional device.The observed performance decrease seems to most likely attributable to device unrelated clinical reasons, namely a possible side effect of hbot.In addition, it was reported that the user will need further brain radiation that might require implant removal.However, no plans in this regard have been made yet.

Event Description

The user presented to the surgeon with reports of decreased hearing performance with the device.

• 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: 15744067
• MDR Text Key: 303161447
• Report Number: 9710014-2022-00848
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737088422
• UDI-Public: (01)09008737088422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2016
• Device Model Number: MI1000 MED-EL CONCERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2014
• 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: 43 YR
• Patient Sex: Male