MAUDE Adverse Event Report: SONOVA AG PHONAK AUDÜO L90-RT

Model Number	050-1000-P5
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Headache (1880); Vertigo (2134); Neuralgia (4413)
Type of Reportable Event	Serious Injury
Event or Problem Description
Hcp has reported that a patient heard tones from her hearing aid and experienced the device getting very hot and burning her behind the ear.The patient has immediately removed the device and noted it was hot to touch, especially at the bottom, where the charging contacts are located.After the incident the patient reported headache, pain above her right eye, around the right temple and cheek bone, back of her head and right side of the neck.Ent has confirmed that there was no physical burn but suggested that the incident has triggered a trigeminal neuralgia.The patient is being treated with tylenol and prednisone steroids.As of december 7, the patient is still experiencing facial pain, headaches and pain above her eye, however, the headaches have improved, and the neck pain has receded.The patient has no history of migraines, headaches, teeth issues or clenching of teeth.General state of teeth was good.The patient has discontinued the use of rechargeable hearing aids and switched to wearing an older non-rechargeable model.Patient has an appointment with neurologist scheduled in january.This is an initial report.Supplemental information will be provided upon availability of the further information.
Additional Manufacturer Narrative
Upon follow up in (b)(6) and (b)(6) 2024, patient indicated that she still has headaches and vertigo, and has been prescribed a treatment which she decided to forgo due to the tiredness resulting from medication intake.The patient has not returned to using the hearing aids.Overheating of the hearing aids due to the failure of the rechargeable battery is a documented risk of the device use intrinsic to the lithium-ion technology.According to the risk assessment and the available post-market data, overheating of the battery is very unlikely to lead to a serious injury to the device user.The manufacturer will continue to monitor similar issues for trends.This is the final report.

• Brand Name: PHONAK AUDÜO L90-RT
• Common Device Name: PHONAK AUDÜO L90-RT
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL ; 6308219589
• MDR Report Key: 18363893
• Report Number: 3005085999-2023-00015
• Device Sequence Number: 7697521
• Product Code: OSM
• UDI-Device Identifier: 07613389478112
• UDI-Public: 07613389478112
• 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
• Report Date (Section B): 11/20/2023

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: 050-1000-P5
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2023
• 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: Female