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 Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/26/2021
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
Reportedly 3 channels are extra-cochlear.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the active electrode migrated post-operatively out of cochlea, namely three channels were extra-cochlea, although a full insertion was achieved at implantation surgery.A revision surgery to re-insert the electrode array was performed, however the electrode backed out of cochlea again afterwards.Revision surgery is planned but no date has been scheduled yet.
Event or Problem Description
Reportedly 3 channels were extra-cochlear.A revision surgery occurred on the (b)(6) 2021 and the array was re-inserted.However, after the surgery the array backed out again.The recipient will be revised when the fixation clip arrives in the us pending approval.
Event or Problem Description
Reportedly 3 channels were extra-cochlear.A revision surgery occurred on the (b)(6) 2021 and the array was re-inserted.However, after the surgery the array backed out again.Revision surgery was pending approval and receipt of fixation clip.The recipient was eventually revised on (b)(6)2022 and the array was completely reinserted.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the active electrode migrated post-operatively out of cochlea, namely three channels were extra-cochlea, although a full insertion was achieved at implantation surgery.A revision surgery to re-insert the electrode array was performed, but the electrode backed out of cochlea again afterwards.Another revision surgery was performed successfully.The device remains implanted and in use.

• 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: 12717486
• Report Number: 9710014-2021-00832
• Device Sequence Number: 14379133
• Product Code: MCM
• UDI-Device Identifier: 09008737366803
• UDI-Public: (01)09008737366803
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2022

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: 01/14/2023
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36709
• Was Device Available for Evaluation?: No
• 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: 10/26/2021
• Supplement Date Received by Manufacturer: 10/26/2021; 10/26/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 01/17/2022; 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male