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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/17/2023
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
On (b)(6) 2023 during rough play the user got hit on the right ear with his sister's elbow.Afterwards he could no longer hear.
Additional Manufacturer Narrative
Conclusion: overload fractures in the active electrode which are consistent with an external mechanical impact were determined to be the root cause of device failure.The active electrode also showed some additional damage to the electrode wires, as being caused by minute device mobility.An accident or impact might have weakened the fixation of the implant, consequently leading to electrode mobility.The problems given in the recipient report appear to match the damage found.This is a final report.
Event or Problem Description
The user's hearing performance with the device is affected after a head trauma occurred.The user was re-implanted.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to reported mechanical impact appears very likely.However, to determine an exact root cause device investigation would be necessary.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The user's hearing performance with the device is affected after a head trauma occurred.The user was re-implanted.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to reported mechanical impact appears very likely.However, to determine an exact root cause device investigation would be necessary.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
Reportedly the user got hit on the head.After that the hearing performance was affected.The user is unilaterally implanted and used to benefit from the device.

• 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: 17786842
• Report Number: 9710014-2023-00830
• Device Sequence Number: 6454555
• Product Code: MCM
• UDI-Device Identifier: 09008737331832
• UDI-Public: (01)09008737331832
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/21/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/05/2021
• Device Model Number: MI1210 SYNCHRONY ST
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 09/19/2023; 09/19/2023; 09/19/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/03/2023; 11/07/2023; 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR
• Patient Sex: Male