MAUDE Adverse Event Report: SONOVA AG PHONAK; NAIDA P30-PR

Model Number	0500807H0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Dizziness (2194)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient has recovered and returned to using hearing aids.The device has been requested to be returned to sonova facility for further analysis.But it has not been yet returned.
Event or Problem Description
Hcp reported that the patient experienced dizziness two days after commencing the use of the phonak naida p30-pr hearing aids, and has been hospitalized due tothe symptoms.Reportedly,the hospital stated that the cause of the issueis likely to be over amplified soundfrom the hearing aids.The patient did not return to using the reported hearing aids and has been re-fit with ric devices in (b)(6) 2023.Patient has had no complaints of dizziness since the original episode.This is an initial report.The investigation isongoing.Supplemental reports will be submitted upon availability of further information.
Additional Manufacturer Narrative
The hcp will not provide any further information on the case and the devices will not be returned for analysis.The device history records do not show any abnormalities in production process.The devices have successfully passed all the prescribed quality tests.This is the final report.

• Brand Name: PHONAK
• Common Device Name: NAIDA P30-PR
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich, che 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL 60504 ; 6308219589
• MDR Report Key: 16947751
• Report Number: 3005085999-2023-00006
• Device Sequence Number: 17731532
• Product Code: OSM
• UDI-Device Identifier: 07613389358513
• UDI-Public: 07613389358513
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/20/2023

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: 0500807H0
• Device Catalogue Number: 050-0807-H0
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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: Unknown