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 Problems Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Date 02/08/2021

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 had his finetuner echo hanging from his neck, using the lanyard provided from the kit.The user stated that, after having the remote all day long under his clothing, the remote got too warm and it felt like a burning sensation.This was the first time that the user had been using the device on his person and under his clothes.It seemed to heat up rapidly and also cool down rapidly when it was removed from skin contact.No error messages were seen.No medical attention was required as it was only a warm feeling.However, mild skin redness was observed from pictures.

Manufacturer Narrative

Conclusion: according to the received information, the finetuner echo got too warm and it felt like a burning sensation.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 had his finetuner echo hanging from his neck, using the lanyard provided from the kit.The user stated that, after having the remote all day long under his clothing, the remote got too warm and it felt like a burning sensation.It seemed to heat up rapidly and also cool down rapidly when it was removed from skin contact.No error messages were seen.New finetuner echo will be shipped to the user's home.

• 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: 11364984
• MDR Text Key: 233047236
• Report Number: 9710014-2021-00107
• 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: 08/20/2021

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
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR