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

Model Number FINETUNER ECHO [FINETUNER 2]

Device Problems Circuit Failure (1089); No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A finetuner echo was returned to service and repair.According to the repair request form, the device had no function.

Manufacturer Narrative

The device 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.

Manufacturer Narrative

Conclusion: according the information received, a finetuner echo was sent to service _ repair due to not functioning.During device investigation a failed capacitor was detected which was clearly the reason for the reported issue.Electrical inspection could not be performed because of the observed malfunction.No injury was reported.This is a final report.

Event Description

A finetuner echo was returned to service and repair.According to the repair request form, the device had no function.No injury has been reported.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: EXTERNAL COMPONENT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 17498434
• MDR Text Key: 320888201
• Report Number: 9710014-2023-00698
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737373429
• UDI-Public: (01)09008737373429
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FINETUNER ECHO [FINETUNER 2]
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Male