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 Output Problem (3005)

Patient Problem Burning Sensation (2146)

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device 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 reported that the finetuner echo had been getting warm up to the point that the user dropped it and the battery fell out.When the recipient attempted to pick up the battery it "burned her finger" but that was rectified with the application of ice cubes.

Manufacturer Narrative

Conclusion: according to the received information, the finetuner echo got warm up to the point that the user dropped it and the battery fell out.During device investigation a failed capacitor was detected which was likely the reason for the observed issue.This is a final report.

Event Description

The user reported that the finetuner echo had been getting warm up to the point that the user dropped it and the battery fell out.The device has been returned to headquarters.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: EXTERNAL COMPONENT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 12074862
• MDR Text Key: 258706270
• Report Number: 9710014-2021-00466
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737344290
• UDI-Public: (01)09008737344290
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• 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: 08/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR