MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; LINX QUATTRO 9

Model Number	RE9MIH-W-UP,LINX QUATTRO 9,GN RESOUND
Medical Device Problem Codes	Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hearing Impairment (1881)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We will not be able to finalize investigation in time for the 30 day time limit, why this is an initial report.
Event or Problem Description
As reported by customer service: hearing aid back from remake and screeching.Has not been able to fit her patient.First the aid would not connect, she sent it back and now the aid screeches.Interpretation by corporate quality, pms team: the perceived loud sound level of the device can potentially harm the remaining hearing of the patient.No indications of any such harm is provided in the complaint, but it cannot be ruled out.The device is equipped with a ultra power receiver.
Additional Manufacturer Narrative
The device has now been returned to us the manufacturer for investigations.Our electro accustic (ea) department have investigated the device and their investigation reveals that the device is performing according to specifications and that the screeching is caused by an incorrect dfs calibration (the initial setting of the device done by and at the dispenser).Clinical conclusion on the case is that the device is performing according to specifications and that it is evaluated unlikely that the feedback would cause harm to residual hearing.Final conclusion is therefore that the case is not reportable.
Event or Problem Description
As reported by customer service: hearing aid back from remake and screeching.Has not been able to fit her patient.First the aid would not connect, she sent it back and now the aid screeches.Interpretation by corporate quality, pms team: the perceived loud sound level of the device can potentially harm the remaining hearing of the patient.No indications of any such harm is provided in the complaint, but it cannot be ruled out.The device is equipped with a ultra power receiver.

• Brand Name: GN RESOUND
• Common Device Name: LINX QUATTRO 9
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, copenhagen 2750 ; DA 2750
• MDR Report Key: 10481501
• Report Number: 3005650109-2020-00030
• Device Sequence Number: 17167152
• Product Code: OSM
• UDI-Device Identifier: 05708296176533
• UDI-Public: 05708296176533
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,Followup
• Report Date (Section B): 10/28/2020

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: RE9MIH-W-UP,LINX QUATTRO 9,GN RESOUND
• Device Catalogue Number: 21227300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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: Disability