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

Model Number FINETUNER ECHO [FINETUNER 2]

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

The finetuner echo shows a bulging bubble on its backside.It has already been replaced by the acoustician.

Manufacturer Narrative

Conclusion: according to the information received, a bulge was detected on the backside of the fine tuner echo.During device investigation a defective 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

The fine tuner echo shows a bulging bubble on its backside.The bulge is located on the qr-code/serial number, between the battery and the lower end of the finetuner echo.There was no report of the device heating up.The device has been replaced.

• 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: 16911596
• MDR Text Key: 315014867
• Report Number: 9710014-2023-00396
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737373429
• UDI-Public: (01)09008737373429
• 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: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 05/05/2023
• Supplement Dates FDA Received: 08/10/2023
• 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: 66 YR
• Patient Sex: Male