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 Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The recipient has effective use of the right side device and was able to understand sentences in silence (77%) and in noise (51%), without performance deterioration.However, he reported that when he uses the audio processor (ap) on the right, he felt like a stimulation, a "resound of the sound".When the ap was turned off, the problem was not reported.Another ap was already tested and resulted in the same outcome.Further proceedings are unknown.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.Further the recipient experienced an echo of the sound due to undetermined reasons.However, to determine an exact root cause a device investigation is necessary.No information has been received for investigation yet.
Event or Problem Description
The recipient has effective use of the right side device and was able to understand sentences in silence (77%) and in noise (51%), without performance deterioration.However, he reported that when he uses the audio processor (ap) on the right, he felt like a stimulation, a "resound of the sound".When the ap was turned off, the problem was not reported.Another ap was already tested and resulted in the same outcome.Further proceedings are unknown.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.Further the recipient experienced an echo of the sound due to undetermined reasons.However, to determine an exact root cause a device investigation is necessary.Reportedly, the recipient still has some hearing benefit with the device.No information on possible further steps has been received.
Event or Problem Description
The recipient has effective use of the right side device and was able to understand sentences in silence (77%) and in noise (51%), without performance deterioration.However, he reported that when he uses the audio processor (ap) on the right, he felt like a stimulation, a "resound of the sound".When the ap was turned off, the problem was not reported.Another ap was already tested and resulted in the same outcome.The reported performance evaluation was done for the right side device.The audiologist said that the recipient was happy with the device, but he feels that the comprehension is worsening.

• 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: 17478245
• Report Number: 9710014-2023-00680
• Device Sequence Number: 11412561
• Product Code: MCM
• UDI-Device Identifier: 09008737049157
• UDI-Public: (01)09008737049157
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 08/05/2024

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: 04/06/2024
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 08/01/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/20/2023; 08/05/2024
• Date Device Manufactured: 04/06/2021
• 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: 48 YR
• Patient Sex: Male