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]

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Discomfort (2330)

Event Date 04/10/2023

Event Type  malfunction  

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 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.

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 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.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: 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
• MDR Text Key: 313736626
• Report Number: 9710014-2023-00328
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737349530
• UDI-Public: (01)09008737349530
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: SONNET 2 CONTROL UNIT EAS [OPUS 4 CPU EAS]
• Device Catalogue Number: 36904
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 04/10/2023
• Supplement Dates FDA Received: 06/20/2023
• Date Device Manufactured: 05/23/2022
• 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 Age: 4 YR
• Patient Sex: Female