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

Model Number	MI1000 MED-EL CONCERT PIN
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
The user underwent a revision surgery to reposition the device, during which the development of a cholesteatoma was verified.It was then decided to explant the device.
Additional Manufacturer Narrative
The device has been explanted and 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
Hearing performance with the device was reportedly affected and the user underwent a revision surgery to reposition the device.During the surgery it has been verified that a cholesteatoma had developed and it was then decided to explant the device.No new device has been implanted.No further information has been received, despite requested.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during the investigation are attributable to the removal surgery.According to the information received from the field the recipient underwent a revision surgery to re-position the device.Available information indicate that the electrode array has most likely post-operatively moved out of the cochlear.However, this has not been confirmed.The observed cholesteatoma might have contributed.This is a final report.

• 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: 15402125
• Report Number: 9710014-2022-00667
• Device Sequence Number: 5057367
• Product Code: MCM
• UDI-Device Identifier: 09008737062736
• UDI-Public: (01)09008737062736
• 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: 2022
• 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
• Report Date (Section B): 12/07/2022

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 Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 07679
• 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: 09/05/2022
• Supplement Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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