MAUDE Adverse Event Report: SONOVA AG PHONAK LYRIC4; PHONAK LYRIC4 (M)

Model Number	078-0063
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hearing Impairment (1881)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the lyric4 device has been removed from the patient's ear on the 66th day of wear.Hcp noted that the reason for removal was discomfort.Upon removal hcp has remarked that the patient has experienced sudden hearing loss which may be related to the advanced age of the patient.The manufacturer has so far not managed to rule out the contributing role of the device in the reported incident.The current location of the device in unknown.This is the initial report.The follow up is ongoing.Supplemental reports will be submitted upon obtaining additional information.
Additional Manufacturer Narrative
The current location of the device is unknown.
Additional Manufacturer Narrative
No remedial actions were reported.It was confirmed that the patient did not visit an ent doctor.The device was not returned for analysis.It has been confirmed in the follow up that the hcp does not contribute patient's hearing loss to the use of the device.Therefore, the manufacturer rules out that the reported incident was caused by the device.This is the final report.

• Brand Name: PHONAK LYRIC4
• Common Device Name: PHONAK LYRIC4 (M)
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL 60504 ; 6308219589
• MDR Report Key: 19033307
• Report Number: 3005085999-2024-00008
• Device Sequence Number: 12803699
• Product Code: ESD
• UDI-Device Identifier: 07613389250893
• UDI-Public: (01)07613389250893
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/19/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 078-0063
• Device Catalogue Number: 078-0063
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• 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