MAUDE Adverse Event Report: SONOVA AG PHONAK LYRIC4 (XXS)

Model Number	078-0060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Sonova ag is informed by the health care professional that the listed device has been involved in an incident leading to tm perforation.Follow up on the details of the incident indicates device was i use for 44 days and incident occurred during the scheduled removal procedure.According to the hcp the cause of the incident was that the patient suddenly moved their head leading to the tm penetration.The patient was sent to visit ent.The patient is now on ear rest.Tm perforation are normally self healing injuries.No further complications were reported.There is no evidence of device malfunction or user error.The root cause of the mild injury is related to the removal procedure.
Additional Manufacturer Narrative
Follow up on the details of the incident indicates device was i use for 44 days and incident occurred during the scheduled removal procedure.According to the hcp the cause of the incident was that the patient suddenly moved their head leading to the tm penetration.The patient was sent to visit ent.The patient is now on ear rest.Tm perforation are normally self healing injuries.No further complications were reported.There is no evidence of device malfunction or user error.The root cause of the mild injury is related to the removal procedure.
Event or Problem Description
Sonova ag is informed by the health care professional that the listed device has been involved in an incident leading to tm perforation.

• Brand Name: PHONAK LYRIC4 (XXS)
• Common Device Name: PHONAK LYRIC4 (XXS)
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich,che 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; stafa, zurich, IL 8712 ; SZ 8712 ; 6308219589
• MDR Report Key: 19712583
• Report Number: 3005085999-2024-00015
• Device Sequence Number: 8513223
• Product Code: ESD
• UDI-Device Identifier: 07613389250862
• UDI-Public: 07613389250862
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 06/07/2024

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: Health Professional
• Device Model Number: 078-0060
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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