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

Model Number BUTTON PROCESSOR 3 CONTROL UNIT [ME1550]

Device Problem Overheating of Device (1437)

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

Event Date 01/23/2023

Event Type  malfunction  

Event Description

The user's device reportedly melted around the magnet area during the charging process.Further information has been requested.

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.

Manufacturer Narrative

Additional information: according to the information received from the field the rondo 3 audio processor was melting at the magnet site whilst charging.It is assumed that the audio processor was placed with the wrong site on the charger.However as the device has not been received for investigation a root cause for the reported issue cannot be determined.

Event Description

The user's device reportedly melted around the magnet area during the charging process.The user was not harmed in any way by the heating of the device.

• 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: 16272380
• MDR Text Key: 308501186
• Report Number: 9710014-2023-00089
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737392468
• UDI-Public: (01)09008737392468
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/25/2023

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: BUTTON PROCESSOR 3 CONTROL UNIT [ME1550]
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 38 YR
• Patient Sex: Female