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)
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
The user went to the clinic for a routine mapping and changes in telemetry were detected.Re-implantation is considered.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode, as it might be caused by an external mechanical impact appears likely.However to confirm an exact root cause of failure a device investigation of the explanted device is necessary.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The user went to the clinic for a routine mapping and changes in telemetry were detected.The user has been re-implanted on (b)(6) 2023.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode, as it might be caused by an external mechanical impact appears likely.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 went to the clinic for a routine mapping and changes in telemetry were detected.Re-implantation is considered, but no date has been set yet.
Additional Manufacturer Narrative
Conclusions: the investigation results revealed overload fractures in the active electrode confirming that the device has failed due to an external impact to the active electrode.All the problems given in the recipient report appear to match well with this finding.
Event or Problem Description
The user went to the clinic for a routine mapping and changes in telemetry were detected.The user has been re-implanted on (b)(6) 2023.

• 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: 17266245
• Report Number: 9710014-2023-00570
• Device Sequence Number: 5910958
• Product Code: MCM
• UDI-Device Identifier: 09008737062712
• UDI-Public: (01)09008737062712
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/27/2024

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: 03/30/2024
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 07678
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 06/28/2023; 06/28/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 09/08/2023; 01/15/2024; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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: 3 YR
• Patient Sex: Male