MAUDE Adverse Event Report: GN HEARING A/S RESOUND; LINX2

Model Number	LS561-DRW
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hearing Impairment (1881)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Outcome: almost painful sound.S/n (b)(4) - left.No information (was not possible to select within esubmitter).Mfg date: 11/19/2016 - left.
Event or Problem Description
End-user complained of hearing sharp almost painful intermittently sound in one or both ears.
Additional Manufacturer Narrative
Additional info from b2: almost painful sound.Additional info from d4: s/n (b)(6) - left.Additional info from d10: no information (was not possible to selct within esubmitter).Additional info from h4: 11/19/2016 - left.Additional information from g7: we consider this report to be final.Additional information from h2: information added 02/13/2020: device not returned to manufacturer.The patient status is (b)(6) 2020 confirmed to be that the patient is now fine without any complications from the event.The case has been reviewed from a clinical perspective.Customer reported: one time the end user has experienced a loud sound in one or two ears.End user described the sound as painful and removed the devices and restarted the devices immediately.There are no reports of harm.Receiver type is an ultra power receiver.The noah file however revealed that the hcp might have set up one device to be an medium power at last visit.Devices not received for investigation.Mpo is on datasheet 129 db spl (2 cc coupler) and set up to 130 db spl (711 coupler) ref.Noah file.The clinical evaluation for the device family does evaluate loud sounds and this is addressed in the risk analysis and mitigated to an acceptable limit by built-in protective measures in the device design.It is unknown if this was an external loud sound amplified by the devices or if the devices produced the sound.It is also unknown how loud the sound was, but there is no indication that this would have exceeded mpo so a worst case of 129 db spl (2 cc) can be assumed.A brief exposure to this sound level can be highly unpleasant but is within the fitting of the devices for this hearing-impaired patient.As there is no other indication that there was harm to the residual hearing of the patient, it is at this point in time concluded that it is unlikely that there was harm.Based on the above the manufacturer have decided to re-classify this complaint to a non-safety related complaint and also thereby concluded that this related event is not reportable.Please disregard this case from the list of reportable cases.
Event or Problem Description
End-user complained of hearing sharp almost painful intermittently sound in one or both ears.

• Brand Name: RESOUND
• Common Device Name: LINX2
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 9579513
• Report Number: 3005650109-2020-00001
• Device Sequence Number: 14002647
• Product Code: OSM
• UDI-Device Identifier: 05704819267290
• UDI-Public: 05704819267290
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: LS561-DRW
• Device Catalogue Number: 19420902
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/12/2020
• Supplement Report FDA Received Date: 02/13/2020
• 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: Other