MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; LT961-DRW,RESOUND LINX3D 9

Model Number	LT961-DRW,RESOUND LINX3D 9,GN RESOUND
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Irritation (2076); Partial Hearing Loss (4472)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case has been reviewed retrospectively as part of capa (b)(4) and it has been decided to be reportable.(background: a software error has evaluated 21 cases as non-potential safety events.The retrospective review has evaluated 4 of the 21 as reportable.The sw error has been corrected).In this case there has not been reported any serious injury (no permanent harm, no medical or surgical intervention).The device may have malfunctioned (no samples available for test) and it cannot be ruled out that it - theoretically - can cause or contribute to a serious injury should it recur.This is due to it's a high power device.This is considered a single incident and will be included in regular trending.No corrective actions has been initiated based on this individual event.
Event or Problem Description
As reported by the local hearing aid dealer: aids beep "a couple times and then 'boom! they get real loud" - painful.Patient has not seen physician and has continued to wear aids but they suddenly get really loud.No explanation with cursory review of settings except cr's very high and erratic, reaching gain curve at some frequencies.Have the symptom(s) disappeared completely? yes.

• Brand Name: GN RESOUND
• Common Device Name: LT961-DRW,RESOUND LINX3D 9
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, copenhagen 2750 ; DA 2750
• MDR Report Key: 10526989
• Report Number: 3005650109-2020-00035
• Device Sequence Number: 3016251
• Product Code: OSM
• UDI-Device Identifier: 05704819289605
• UDI-Public: 05704819289605
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: LT961-DRW,RESOUND LINX3D 9,GN RESOUND
• Device Catalogue Number: 19706501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention