MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; EXTERNAL COMPONENT

Model Number	SONNET 2 CONTROL UNIT EAS [OPUS 4 CPU EAS]
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/10/2023
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 user was implanted on (b)(6) 2022 on the left ear, and was activated and was using her external device without any problem until the surgery of the contra lateral right ear on (b)(6) 2023.After this surgery, the child did not want to wear the external device anymore and complained about pain when using it, throwing it away every time the parents wanted to put it on her left ear.Per new information received, the user was given a new processor to try at home.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient experienced painful sensations with the use of the audioprocessor.Reportedly no further issues are reported with a new audioprocessor.However to determined an exact root cause a device investigation would be necessary.The concerned device has not been received for investigation yet.Please note: the initial report was submitted for the implant, mi1250 synchrony 2 flex26 sn (b)(6).However, since the issue was due to the audioprocessor, the product type was changed.This event can lead to the inconvenience of requiring the external device to be exchanged through regular service activities, but no detrimental impact on user_s safety is observed or expected.Therefore this case is per se no longer deemed reportable,.
Event or Problem Description
The user was implanted on (b)(6)2022 on the left ear, and was activated and was using her external device without any problem until the surgery of the contra lateral right ear on 08-mar-2023.After this surgery, the child did not want to wear the external device anymore and complained about pain when using it, throwing it away every time the parents wanted to put it on her left ear.Only bipolar cautery was used at implantation of the contra-lateral device.Mapping can be ruled out as an issue since the user does not even tolerate stimulation levels lower than those of activation.The user was given a new ap to try at home.As of (b)(6)2023 it was reported that the user is using the loaner ap without any issue still.The ap which caused the reported symptoms will be returned once a new ap for the user arrives.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient experienced painful sensations with the use of the audio processor (sonnet 2).The audio processor was exchanged and reportedly no further issues are reported with a new audio processor.The investigation of the concerned device revealed a fully functional device, which works within specification.The investigation only showed parts of the imprint being detached, signs of use on the housing and minor contamination on the microphones which has no impact on the functionality of the device.A root cause for the reported pain cannot be determined.This is a final report.
Event or Problem Description
The user was implanted on (b)(6) 2022 on the left ear and was activated and was using her external device without any problem until the surgery of the contra lateral right ear on (b)(6) 2023.After this surgery, the child did not want to wear the external device anymore and complained about pain when using it, throwing it away every time the parents wanted to put it on her left ear.Only bipolar cautery was used at implantation of the contra-lateral device.Mapping can be ruled out as an issue since the user does not even tolerate stimulation levels lower than those of activation.The user was given a new ap to try at home.As of (b)(6) 2023, it was reported that the user is using the loaner ap without any issue.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: EXTERNAL COMPONENT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 16782711
• Report Number: 9710014-2023-00328
• Device Sequence Number: 5781455
• Product Code: MCM
• UDI-Device Identifier: 09008737349530
• UDI-Public: (01)09008737349530
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/23/2025
• Device Model Number: SONNET 2 CONTROL UNIT EAS [OPUS 4 CPU EAS]
• Device Catalogue Number: 36904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 04/10/2023; 04/17/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/20/2023; 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 4 YR
• Patient Sex: Female