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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Impedance Problem (2950); Output Problem (3005)
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
This user has started experiencing continued issues with the left device.Programming changes were made in july 2022 to address two affected channels and in october 2022 the recipient started noticing perceptual sound changes in the left ear only when turning or tilting the head, and when pushing on his left tragus.On (b)(6) 2022 an integrity test was completed due to concerns of fluctuations with impedances and perceptual sound changes.The sound changes are described as making sounds more base like and muffled.This seems to affect lower frequency voices.This happens while walking and looking around, while driving, and while leaning on his fist.Also, it has also been noticed since july 2022 that his implant housing appears to be moving.A revision surgery is considered.
Additional Manufacturer Narrative
Conclusions: damage to the active electrode caused by device minute mobility likely led to device failure.During investigation the exact location of damage could not be determined due to the device's received condition.Other observed mechanical damages are attributable to the removal surgery.However, a decrease in hearing performance was reported, and in situ measurements show various channels with increased impedance values and fluctuations during continuous measurements.Furthermore, the observed changes in sound perception with movement or pressure are compatible with the above-mentioned damage.In addition a dislocation of the device from its intended position was observed at removal surgery.This is a final report.
Event or Problem Description
The user started experiencing continued issues with the left device.Programming changes were made in (b)(6), 2022 to address two affected channels and in (b)(6), 2022 the recipient started noticing perceptual sound changes in the left ear only when turning or tilting the head, and when pushing on his left tragus.On (b)(6), 2022 an integrity test was completed due to concerns of fluctuations with impedances and perceptual sound changes.The sound changes are described as making sounds more base-like and muffled.This seems to affect lower frequency voices.This happens while walking and looking around, while driving, and while leaning on his fist.The user was re-implanted.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• 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: 15788557
• Report Number: 9710014-2022-00867
• Device Sequence Number: 12112870
• Product Code: MCM
• UDI-Device Identifier: 09008737366766
• UDI-Public: (01)09008737366766
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 02/24/2023
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• 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: 23 YR
• Patient Sex: Male