MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Model Number SONATA

Device Problem Noise, Audible (3273)

Patient Problem Discomfort (2330)

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

Conclusion: the received information from the field indicates uncomfortable hearing sensation with the device by hearing a static noise.Device investigation found a reduced impedance between coil and stimulator housing.However, it remains unknown if these findings could have caused the reported noise and performance issues.Further, also the reason for the reduced impedance is unclear.Hence, the root cause for the observed findings could not be determined during device investigation and remains unknown.The recipient has been explanted and implanted with a new device.This is a combined initial and final report.

Event Description

The recipient reported "white noise" through the audio processor.Performance on in situ testing (b)(6) 2023 was poorer than it had been in recent years.The recipient has been re-implanted.

• Brand Name: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
• Type of Device: 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: 18737152
• MDR Text Key: 336864658
• Report Number: 9710014-2024-00154
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male