MAUDE Adverse Event Report: SONOVA AG LYRIC4; HEARING AID, COMPLETELY-IN-CANAL

Model Number	078-0061
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has initiated an investigation.It was established that the device was removed by ent, who also advised that the ear was sore and gave the patient an ointment.The investigation is ongoing.This is the initial report.Follow up will be submitted upon availibilty of additional information.
Event or Problem Description
It has been reported that on the hcp's attempt to remove lyric from a patient's ear, part of the device totally snapped off and the hcp was unable to remove the device from patient's ear.The patient was sent for an urgent private ent appointment.
Additional Manufacturer Narrative
The device was removed by ent, who advised that the ear was sore and gave the patient an ointment.Despite several due attempts the information on the type of ointment was not obtained.The manufacturer has requested the device to be returned for analysis, however the device was not available for return.Despite manufacturers repeated attempts to obtain more details on the circumstances of the event from the hcp, the information provided does not allow to determine the exact root cause of this incident.In the corresponding risk file of the device, several risks have been identified to assess risks associated with the removal procedure.Without further details it is not possible, however, to link the incident to an exact risk from the device risk file.The user guide of the device contains dedicated sections on removing and replacing the device.The detailed instruction of the removal procedure is also described in the fitting guidelines document intended for hcps.This is the final report.

• Brand Name: LYRIC4
• Common Device Name: HEARING AID, COMPLETELY-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stäfa, zürich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisrütistrasse 28; stafa, zurich 8712 ; SZ 8712
• MDR Report Key: 20840597
• Report Number: 3005085999-2024-00023
• Device Sequence Number: 17076192
• Product Code: ESD
• UDI-Device Identifier: 07613389250879
• UDI-Public: (01)07613389250879
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 078-0061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female