MAUDE Adverse Event Report: SONOVA AG LYRIC 4; 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.The request for additional information was issued to gather information on the circumstances of the event and the outcome to the patient.The device was requested to be returned to the manufacturer for analysis.The investigation is ongoing.This is the initial report.Supplemental reports will be submitted upon obtaining additional information.
Event or Problem Description
It has been reported that the device got stuck and a front panel came off during the procedure of scheduled removal by the hcp.The patient was sent to ent, who removed the device and treated trauma.
Additional Manufacturer Narrative
The hcp did not respond to the manufacturer's follow up requests regarding the circumstance of the incident despite several follow up attempts.This event was reported by the same clinic as case #(b)(4) for which a vigilance reports is already filed to the mhra ref.#: (b)(4).Both cases #(b)(4) (this one) and #(b)(4) contained similar initial information on the incident reported for two different serial numbers of the devices (b)(6), respectively.Manufacturer has reviewed the available fitting data in the system to find out that both serial numbers were recorded to be fitted by the same hcp to the same patient one after another.However, the date device (b)(6) was recorded to be fitted ((b)(6)2024) does not align with the narrative the manufacturer has received from the hcp for (b)(6) when investigating #(b)(4).According to which (b)(6) has been removed by ent on (b)(6)2024.For this reason and taking into account that the hcp never responded to follow up questions regarding the case being the subject of this report (#(b)(4), sn (b)(6)) the manufacturer has reason to suspect that this incident and an already reported one #(b)(4) (mhra ref.#: (b)(4)) concern a single occurrence, incorrectly entered twice into the system.This however could not have been confirmed with the hcp.

• Brand Name: LYRIC 4
• 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; stäfa, zürich 8712 ; SZ 8712
• MDR Report Key: 20922440
• Report Number: 3005085999-2024-00028
• Device Sequence Number: 18240368
• Product Code: ESD
• UDI-Device Identifier: 07613389250879
• UDI-Public: (01)07613389250879
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 11/29/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/27/2025
• Date Device Manufactured: 07/26/2024
• 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: Unknown