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)
Type of Reportable Event	Malfunction
Event or Problem Description
The user's hearing performance is affected after a head trauma occurred in (b)(6) 2022.
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's hearing performance is affected after a head trauma occurred in (b)(6) 2022.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to the reported trauma appears very likely.Further, in situ measurements showed three channels with high impedance already before the reported impact due to undetermined reasons.In addition, a complete insertion was not achieved at implantation surgery with two electrodes remaining extra-cochlear.However, to confirm an exact root cause device investigation would be necessary.Re-implantation is not planned at the moment.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to the reported trauma appears very likely.Further, in situ measurements showed three channels with high impedance already before the reported impact due to undetermined reasons.In addition, a complete insertion was not achieved at implantation surgery with two electrodes remaining extra-cochlear.However, to confirm an exact root cause device investigation would be necessary.Re-implantation was carried out, but the device has not been received yet.
Event or Problem Description
The user's hearing performance is affected after a head trauma occurred in (b)(6) 2022.The user was re-implanted.
Additional Manufacturer Narrative
Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue breakages.Also, an impact to the head might have weakened the fixation of the active electrode and could also be a factor for electrode mobility.In addition, a complete insertion was not achieved at implantation surgery with two electrodes remaining extra-cochlear.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
Event or Problem Description
The user's hearing performance is affected after a head trauma occurred in (b)(6) 2022.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: 16282314
• Report Number: 9710014-2023-00092
• Device Sequence Number: 6785623
• 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): 08/31/2023

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: 06/25/2022
• Device Model Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 33334
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 01/31/2023; 01/31/2023; 01/31/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 05/11/2023; 08/01/2023; 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2019
• 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: 7 YR
• Patient Sex: Female