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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it is to 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's hearing performance with the device is affected.
Additional Manufacturer Narrative
Conclusions: device investigation did not reveal any device defect or damage which is expected to have been present whilst implanted.Damage found during device investigation is reportedly related to the revision surgery, where the electrode lead was inadvertently cut.According to the received information, the revision surgery was performed because the implant housing migrated from its intended position and caused pain.In addition, a migration of the active electrode out of cochlea was observed following the implant movement.The problems given in the recipient report match the damage found.This is a final report.
Event or Problem Description
The user's hearing performance with the device was affected.A movement of the implant housing was suspected, which caused extra-cochlear channels as well.The user could no longer hear with the device and reported pain.The recipient has been reimplanted.The revision surgery was performed to reposition the device and fix it with non-absorbable sutures.However, accidentally the electrode lead was cut and a new device was implanted.According to the device explantation report form, 4 channels were found extra-cochlear.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 11443014
• Report Number: 9710014-2021-00150
• Device Sequence Number: 17048603
• Product Code: MCM
• UDI-Device Identifier: 09008737366728
• UDI-Public: (01)09008737366728
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 04/27/2021

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 Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR