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

Model Number	078-0065
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for analysis.
Event or Problem Description
Upon removal of the lyric device the hcp has referred patient to ent due to posterior tempanic membrane perforation and keratin debris in the middle ear space.Currently, the manufacturer could not confirm that the device did not contribute to the incident.This is the initial report.The follow up is ongoing.Supplemental reports will be submitted upon availability of further information.
Additional Manufacturer Narrative
27.03.2024 upon follow up, the device has been removed from the ear by an ent on the 20th of december at a scheduled appointment after 70 days of wear.There are no pictures of the device available and the device has been discarded.The ent observed that the left auditory canal was normal, but there was posterior tympanic membrane perforation with non-infected keratin debris in middle ear space.The ent provided medical assistance at the same appointment.The ent is not aware of any accompanying medical conditions in the patient that could have contributed to the event.The patient has been initially fitted with lyric4 at a different clinic.The ent reporting the incident does not consider that the patient is a good candidate for wearing lyric due to her level of hearing loss and a history of seeing blood upon device removal.The ent discourages the further use of lyric4.A surgery is not recommended given the age of the patient.The patient has transitioned to using daily wear hearing aids.The manufacturer was not able to exclude that the lyric device has contributed to the reported incident.There was no indication that the device has malfunctioned or otherwise not performed as expected.The device is not available for further investigation, therefore the root cause determination cannot be performed.
Additional Manufacturer Narrative
(b)(6) 2024 upon further follow up, the patient was prescriped ear rest and medication was not prescribed.The patient switched from deep insertion to daily wear and health of ear has improved.The ent confirmed that she/he does not relate the incident to the use of lyric device.This is the final report.

• Brand Name: PHONAK LYRIC4 (XL)
• Common Device Name: PHONAK LYRIC4 (XL)
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa,zurich 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL
• MDR Report Key: 18564505
• Report Number: 3005085999-2024-00002
• Device Sequence Number: 6660864
• Product Code: ESD
• UDI-Device Identifier: 07613389250916
• UDI-Public: 07613389250916
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 12/20/2023

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: 078-0065
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 12/20/2023; Not provided
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 03/28/2024; 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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