MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA; COCHLEAR IMPLANT

Model Number	SONATA
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportedly, the user can only hear properly when he is pushing on the implant side.Further technical checks are scheduled for the next 1-2 weeks.
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.Furthermore, in situ measurement show a fluctuating ground path impedance, which is likely caused by a temporary air bubble above the implant site.However, to determine an exact root cause a device investigation of the explanted device is necessary.Currently the hearing perception is still satisfactory.The device remains implanted and in use.This is a final report.
Event or Problem Description
Reportedly, the user can only hear properly when he is pushing on the implant side.The field suspects air around the implant body.Per new information received on 19-nov-2024, the user hears fine as before.Positioning of the coil is normal and there is no need to apply pressure anymore to hear.The user is satisfied with the current hearing and does not want any further changes, and certainly not any kind of intervention.

• Brand Name: SONATA
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 20692872
• Report Number: 9710014-2024-01021
• Device Sequence Number: 8701329
• Product Code: MCM
• UDI-Device Identifier: 09008737049171
• UDI-Public: (01)09008737049171
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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 Expiration Date: 10/13/2017
• Device Model Number: SONATA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/11/2024
• Date Device Manufactured: 10/13/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 43 YR
• Patient Sex: Male