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

Model Number MI1000 MED-EL CONCERT

Device Problems Insufficient Information (3190); Lack of Effect (4065)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2023

Event Type  malfunction  

Event Description

The user has been re-implanted on (b)(6) 2023, because the hearing performance decreased.

Manufacturer Narrative

The device has been explanted and 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 has been re-implanted on (b)(6) 2023 because the hearing performance decreased.No exact date could be proved as the hearing performance with the was never too good and the benefit was limited.

Manufacturer Narrative

Conclusion: no available information is pointing to the device having caused or contributed to the poor hearing benefit since implantation.The 6 most basal channels have been deactivated since june 2016 due to non-auditory side effects and _echoes_.In situ measurements at that time were indicative of a fully functional device and the electrode array was found fully inserted at the time of explantation.The two channels involved in one short circuit observed since june 2017 had already been disabled in 2016; therefore, no timely correlation between the short circuit and reported poor hearing performance can be established.Explant investigation did not reveal a technical problem.The short circuit between two implant channels observed, could not be located during investigation.This is a final report.

• 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: 16633506
• MDR Text Key: 312217240
• Report Number: 9710014-2023-00255
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737076702
• UDI-Public: (01)09008737076702
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 09/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/07/2017
• Device Model Number: MI1000 MED-EL CONCERT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female