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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The electrode array may have additionally migrated after an incomplete insertion at implantation.Reimplantation will be scheduled.
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 electrode array may have additionally migrated after an incomplete insertion at implantation.The user was re-implanted on the (b)(6) 2021.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the active electrode likely migrated partially out of cochlea, leading to decreased benefit.In addition an incomplete insertion at the time of implantation is reported.In situ measurements show hi impedance on one apical channel for undetermined reasons.To determine an exact root cause, device investigation at the explanted device would be necessary.The explanted device has not been received for investigation yet.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.Based on the received information from the field, the active electrode likely migrated partially out of cochlea, leading to decreased benefit.In addition an incomplete insertion at the time of implantation is reported.In situ measurements show hi impedance on one apical channel for undetermined reasons.This is a final report.
Event or Problem Description
The electrode array may have additionally migrated after an incomplete insertion at implantation.The user was initially implanted with an image-guided minimally invasive approach, however the clinic was unable to achieve full insertion and the 2 most basal channels were left extra-cochlear.Then at activation no auditory percept was found on two more channels.The user was re-implanted on the (b)(6) 2021.

• 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: 12819232
• Report Number: 9710014-2021-00878
• Device Sequence Number: 11958873
• Product Code: MCM
• UDI-Device Identifier: 09008737094027
• UDI-Public: (01)09008737094027
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2022

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 Expiration Date: 01/17/2022
• Device Model Number: MI1200 SYNCHRONY
• Device Catalogue Number: 31091
• 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: 11/04/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 11/04/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 03/07/2022; 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2019
• 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: 80 YR
• Patient Sex: Male