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

Model Number	0780065
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial Hearing Loss (4472)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is discarded.Therefore, device analysis is not available for analysis.
Event or Problem Description
Hcp has reported that a patient experienced sudden reduction in hearing.Currently the device relatedness of the incident has not been confirmed.A follow up is ongoing to collect further information about the incident.This is an initial report.Follow up reports will be submitted upon availability of further information.
Additional Manufacturer Narrative
The hcp retested patient's hearing on the day of device's removal and nothing has changed in hearing.The patient was referred to ent, who diagnosed the patient with sudden sensorineural hearing loss.The patient was treated with 2 courses of prednisone and referred for mri.The hcp does not relate this incident to the use of device.The patient has a history of otosclerosis and the ent thought that the hearing loss might be related to that.Currently, the patient is doing great, hearing improved in the affected ear and the patient is back to using lyric bilateraly.This is the final report.
Event or Problem Description
The hcp reported that a patient experienced sudden reduction in hearing.

• Brand Name: PHONAK LYRIC4 (XL)
• Common Device Name: PHONAK LYRIC4 (XL)
• Manufacturer (Section D): SONOVA AG; laubisruetistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; stafa, zurich, IL 8712 ; SZ 8712 ; 6308219589
• MDR Report Key: 18740136
• Report Number: 3005085999-2024-00007
• Device Sequence Number: 15080469
• Product Code: ESD
• UDI-Device Identifier: 07613389250916
• UDI-Public: 07613389250916
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/06/2024

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: 0780065
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2023
• 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: Female