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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2021
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 26sep2021 the family of the user reported that the position of the device has changed and now protrudes more outwards.The family is not able to visit the clinic due to the pandemic and lockdown.Revision surgery may be considered when the lockdown is removed.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device migrated from its intended position post-implantation.However it is reported that the hearing performance is good.The device remains implanted and in use.This is a final report.
Event or Problem Description
The family of the user reported that the position of the device has changed from above the helix to under and protruded more outwards.As per additional information received in november, the user is improving her hearing perception with the device and measurements showed a working implant.Reportedly, the implant position did not change compared to previous observations.No further checks or re-implantation is currently planned.

• 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: 12575443
• Report Number: 9710014-2021-00753
• Device Sequence Number: 11593663
• Product Code: MCM
• UDI-Device Identifier: 09008737366193
• UDI-Public: (01)09008737366193
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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 Expiration Date: 12/09/2023
• Device Model Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 36631
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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
• Patient Age: 30 MO
• Patient Sex: Female