MAUDE Adverse Event Report: SONOVA AG PHONAK; NAIDA P90-UP

Model Number	050-0818-P6
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Acoustic Trauma (1694)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Supporting medical report provided on 25.04.2022 suggests a possible acoustic trauma due to the patient having a narrow dynamic range and receiving too much sound output.The hearing aids could not be obtained for further analysis as the device is scrapped.The company is in the process of obtaining additional information on the case.
Event or Problem Description
On 19.05.2022 patient has been fitted with naida p90-up hearing aids on the 19.04.2022.Later in the evening the patient reported sudden loss of hearing and a constant ringing in the ears after making a phone call.Hearing aid provider has seen the patient on 20.04.2022 and referred to ent with a report of tinnitus and vertigo.On 21.04.2022 after an ent visit the patient has informed the provider that he was diagnosed with acoustic trauma.Supporting medical report provided.On 25.04.2022 suggests a possible acoustic trauma due to the patient having a narrow dynamic range and receiving too much sound output.Patient has been prescribed steroids and returned to using the hearing aids he had before the fitting of new naida p90-up.
Additional Manufacturer Narrative
22.06.2022 three attempts have been made to obtain further information from the customer.Production records of the device do not show any deviations in production process and quality tests.No further information could be obtained.This is the final report.22.06.2022 the hearing aids could not be obtained for further analysis.No corrective / preventive actions have been initiated.The risk file of the device includes risks related to the hazard of loud sound for the residual hearing of the patient.Similar events will be monitored for trends.

• Brand Name: PHONAK
• Common Device Name: NAIDA P90-UP
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL 60504 ; 6308219589
• MDR Report Key: 14464583
• Report Number: 3005085999-2022-00006
• Device Sequence Number: 4482772
• Product Code: OSM
• UDI-Device Identifier: 07613389360110
• UDI-Public: 07613389360110
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/21/2022

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: 050-0818-P6
• Device Catalogue Number: 050-0818-P6
• 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: 04/21/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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