MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH CONCERTO; COCHLEAR IMPLANT

Model Number	MI1000 MED-EL CONCERT PIN
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user's hearing performance with the device is affected.The user's parents noticed that the child did not hear when the right ear processor went off and went to the clinic for troubleshooting.Reimplantation is considered.
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.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the reference electrode, as it might be caused by an external mechanical impact appears likely.In addition, in situ measurements show the most basal channel with high impedance status due to undetermined reasons.However, to confirm an exact root cause of failure a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
The user's hearing performance with the device is affected.The user's parents noticed that the child did not hear when the processor on the contralateral side went off and went to the clinic for troubleshooting.Reimplantation is considered, but no date has been scheduled yet.
Additional Manufacturer Narrative
Conclusion: damage to the reference electrode, likely caused by an external impact, was determined to be the root cause of the device failure.Even though no such causal event, like an accident, is mentioned in the recipient_s report.The investigation results appear to match the high gpi and decreased performance mentioned in the recipients report.In addition, in situ measurements showed the most basal channel with high impedance status due to undetermined reasons.This is a final report.
Event or Problem Description
The user's parents noticed that the child did not hear with the device when the audio processor on the contralateral side was not being used and went to the clinic for troubleshooting.The user has been re-implanted.

• Brand Name: CONCERTO
• 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: 19189854
• Report Number: 9710014-2024-00370
• Device Sequence Number: 18046422
• Product Code: MCM
• UDI-Device Identifier: 09008737083625
• UDI-Public: (01)09008737083625
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2024

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: 02/03/2023
• Device Model Number: MI1000 MED-EL CONCERT PIN
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 04/18/2024; 04/18/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 07/02/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male