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

Model Number	078-0062
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Ear or Labyrinth Problem (4474)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for analysis.
Event or Problem Description
The hcp has reported that a patient has discontinued the use of lyric4 device due to bone exposure in the right ear.The patient will continue using the device in the left ear.The device relatedness of the event could not be clarified prior to report submission.The follow up is ongoing.Supplemental reports will be submitted upon availability of further information.
Additional Manufacturer Narrative
Upon follow-up, the hcp has reported that lyric4 device was removed from the ear during a regular 2-monthly appointment.No pictures were available and device was discarded.The hcp has noted an abrasion in the right ear canal.After removal a physician assisted with removing cerumen after removal.Subsequently, patient was seen by otologist who reported a one by half centimeter exposed bone area, at the bony cartilaginous junction site.The site was painted with gentian violet after cleaning.After 4 weeks, the wet exposed bone area of the ear canal has healed, and the exposed bone is still present under a scab.Currently, the patient is doing better.She continues to use lyric on the left side, but stopped the use of lyric on the right ear where bone exposure occurred.The hcp reports that the patient had a history of otitis media prior to the incident.The manufacturer was not able to exclude the device relatedness of this event based on the information provided.The reported event does not provide any information that suggests that the device has malfunctioned.The device has been discarded by the hcp and cannot be further investigated.
Additional Manufacturer Narrative
The broken receiver has been discarded by the hcp and could, therefore, not be returned for analysis.No further investigation could be conducted.At the time of the event the receiver has been in use for 11 months.Through follow-up, the hcp has confirmed the full recovery of the patient.The patient has returned to using hearing aids on both sides.The manufacturer will monitor similar events for trends.

• Brand Name: PHONAK LYRIC4 (S)
• Common Device Name: PHONAK LYRIC4 (S)
• 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: 18564654
• Report Number: 3005085999-2024-00003
• Device Sequence Number: 6858213
• Product Code: ESD
• UDI-Device Identifier: 07613389250886
• UDI-Public: 07613389250886
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/26/2023

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: 078-0062
• 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: 12/26/2023
• Supplement Date Received by Manufacturer: 12/26/2023; Not provided
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 03/28/2024; 05/06/2024
• 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